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Chemotherapy in Treating Children With Down Syndrome and Myeloproliferative Disorder, Acute Myelogenous Leukemia, or Myelodysplastic Syndrome

Primary Purpose

Leukemia, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Neoplasms

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
asparaginase
cytarabine
daunorubicin hydrochloride
methotrexate
therapeutic hydrocortisone
thioguanine
Sponsored by
Children's Oncology Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leukemia focused on measuring childhood myelodysplastic syndromes, untreated childhood acute myeloid leukemia and other myeloid malignancies, childhood acute myeloblastic leukemia without maturation (M1), childhood acute myeloblastic leukemia with maturation (M2), childhood acute myelomonocytic leukemia (M4), childhood acute erythroleukemia (M6), childhood acute megakaryocytic leukemia (M7), refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, de novo myelodysplastic syndromes, childhood acute minimally differentiated myeloid leukemia (M0), childhood acute monocytic leukemia (M5b), childhood acute monoblastic leukemia (M5a), myelodysplastic/myeloproliferative neoplasm, unclassifiable, juvenile myelomonocytic leukemia, chronic myelomonocytic leukemia, secondary myelodysplastic syndromes

Eligibility Criteria

undefined - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Cytogenetically proven Down Syndrome (constitutional trisomy 21) with transient myeloproliferative disorder (TMD), myelodysplastic syndromes (MDS), or acute myelogenous leukemia (AML) Must be confirmed by bone marrow aspirate, cerebrospinal fluid exam, or blood test Trisomy 21 mosaicism allowed Group I: Diagnosis of TMD in patients no older than 90 days at initial presentation Must have nonerythroid blasts (any amount) in the peripheral blood and one of the following: Verification with a second sample More than 5% bone marrow blasts Hepatomegaly and/or splenomegaly Lymphadenopathy Cardiac or pleural effusions OR Histologically or cytologically proven TMD with blasts in an affected organ or in fluid (pericardial, pleural, or peritoneal) Bone marrow aspirate is required Group II (closed to accrual as of 6/24/04): Diagnosis of MDS or AML (except M3 subtype) in patients older than 90 days with more than 29% blasts in bone marrow (with or without history of TMD), or any of the following histologies: Refractory anemia (RA) RA with excess blasts (RAEB) RAEB in transformation RA with ringed sideroblasts (RARS) Primary cytopenia (later confirmed by bone marrow aspirate as due to marrow hypoplasia) defined by one or more of the following: Absolute neutrophil count less than 500/mm^3 Untransfused platelet count less than 30,000/mm^3 Untransfused hemoglobin less than 8 g/dL The following diagnoses will be observed only: RA with mild cytopenias* RARS with mild cytopenias* Mild primary cytopenias (one or more) without dysplasia (confirmed by hypoplastic bone marrow exam) NOTE: * Platelet count 30-150,000/mm3, absolute neutrophil count 500-1,499/mm3, and hemoglobin greater than 8 g/dL Granulocytic sarcoma (chloroma), with or without bone marrow involvement, allowed PATIENT CHARACTERISTICS: Age: See Disease Characteristics 21 and under Performance status: Not specified Life expectancy: Not specified Hematopoietic: See Disease Characteristics Hepatic: See Disease Characteristics Renal: Not specified Cardiovascular: Shortening fraction greater than 27% by echocardiogram* OR Ejection fraction greater than 47% by radionuclide angiogram* NOTE: *For patients with MDS and AML (as of 2/24/04, previously diagnosed MDS or AML closed to accrual; MDS or AML that develops (secondary to TMD) after study enrollment or MDS that requires initial observation [with or without subsequent treatment] allowed) PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Prior chemotherapy for TMD allowed No prior chemotherapy for malignancy Endocrine therapy: Concurrent topical or inhaled steroids for other conditions allowed Radiotherapy: No prior radiotherapy for malignancy Surgery: Not specified Other: No prior antileukemic therapy Prior enrollment on this study for TMD allowed

Sites / Locations

  • University of Alabama at Birmingham Comprehensive Cancer Center
  • University of South Alabama Cancer Research Institute
  • Phoenix Children's Hospital
  • Arizona Cancer Center at University of Arizona Health Sciences Center
  • Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
  • Southern California Permanente Medical Group
  • City of Hope Comprehensive Cancer Center
  • Rebecca and John Moores UCSD Cancer Center
  • Loma Linda University Cancer Institute at Loma Linda University Medical Center
  • Jonathan Jaques Children's Cancer Center at Miller Children's Hospital
  • Children's Hospital Los Angeles
  • Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center
  • Jonsson Comprehensive Cancer Center, UCLA
  • Children's Hospital Central California
  • Children's Hospital and Research Center at Oakland
  • Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center
  • Children's Hospital of Orange County
  • Lucile Packard Children's Hospital at Stanford University Medical Center
  • Sutter Cancer Center
  • University of California Davis Cancer Center
  • Kaiser Permanente Medical Center - Sacramento
  • Kaiser Permanente Medical Center/Kaiser Foundation Hospital - San Diego
  • Children's Hospital and Health Center, San Diego
  • UCSF Comprehensive Cancer Center
  • Santa Barbara Cottage Hospital
  • Kaiser Permanente Medical Center - Santa Clara
  • David Grant Medical Center
  • Children's Hospital of Denver
  • Presbyterian - St. Luke's Medical Center
  • University of Connecticut Comprehensive Cancer Center at University of Connecticut Health Center
  • Yale Comprehensive Cancer Center
  • Alfred I. duPont Hospital for Children
  • Lombardi Cancer Center at Georgetown University Medical Center
  • Children's National Medical Center
  • Walter Reed Army Medical Center
  • Broward General Medical Center
  • Children's Hospital of Southwest Florida
  • Shands Cancer Center at the University of Florida Health Science Center
  • Joe DiMaggio Children's Hospital at Memorial
  • Nemours Children's Clinic
  • Jackson Memorial Hospital
  • Miami Children's Hospital
  • Baptist Hospital of Miami
  • Florida Hospital Cancer Institute
  • Nemours Children's Clinic-Orlando
  • Sacred Heart Children's Hospital
  • All Children's Hospital
  • St. Joseph's Children's Hospital
  • St. Mary's Hospital
  • AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Scottish RiteCampus
  • MBCCOP-Medical College of Georgia Cancer Center
  • Medical Center of Central Georgia
  • Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
  • Cancer Research Center of Hawaii
  • MBCCOP - Hawaii
  • Tripler Army Medical Center
  • Mountain States Tumor Institute - Boise
  • University of Chicago Cancer Research Center
  • Rush University Medical Center
  • University of Illinois Medical Center
  • Children's Memorial Hospital - Chicago
  • Advocate Hope Children's Hospital
  • Lutheran General Cancer Care Center
  • Saint Jude Midwest Affiliate
  • Southern Illinois University School of Medicine
  • Riley Children Cancer Center at Riley Hospital for Children
  • St. Vincent Hospital and Health Care Center
  • Blank Children's Hospital
  • John Stoddard Cancer Center at Iowa Methodist Medical Center
  • Holden Comprehensive Cancer Center at University of Iowa
  • Wesley Medical Center
  • Markey Cancer Center at University of Kentucky Chandler Medical Center
  • Kosair Children's Hospital
  • MBCCOP - LSU Health Sciences Center
  • Tulane Cancer Center at Tulane University Hospital and Clinic
  • Children's Hospital of New Orleans
  • Ochsner Clinic Foundation
  • Eastern Maine Medical Center
  • Maine Children's Cancer Program
  • Greenebaum Cancer Center at University of Maryland Medical Center
  • Sinai Hospital of Baltimore
  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
  • Floating Hospital for Children
  • Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
  • Baystate Regional Cancer Program at Baystate Medical Center
  • University of Massachusetts Memorial Medical Center - University Campus
  • University of Michigan Comprehensive Cancer Center
  • Children's Hospital of Michigan
  • Josephine Ford Cancer Center at Henry Ford Hospital
  • Van Elslander Cancer Center at St. John Hospital and Medical Center
  • Hurley Medical Center
  • Spectrum Health and DeVos Children's Hospital
  • Bronson Methodist Hospital
  • Breslin Cancer Center at Ingham Regional Medical Center
  • CCOP - Beaumont
  • William Beaumont Hospital - Royal Oak
  • St. Mary's - Duluth Clinic Cancer Center
  • Children's Hospitals and Clinics - Minneapolis
  • Mayo Clinic Cancer Center
  • Children's Hospitals and Clinics - Minnesota
  • University of Mississippi Medical Center
  • Children's Mercy Hospital
  • Cardinal Glennon Children's Hospital
  • St. Louis Children's Hospital
  • Children's Hospital of Omaha
  • UNMC Eppley Cancer Center at the University of Nebraska Medical Center
  • Sunrise Hospital and Medical Center
  • Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
  • Cancer Center at Hackensack University Medical Center
  • Cancer Institute of New Jersey at Robert Wood Johnson University Hospital
  • Newark Beth Israel Medical Center
  • St. Joseph's Hospital and Medical Center
  • Valerie Fund Children's Center at Atlantic Health
  • University of New Mexico Cancer Research and Treatment Center
  • Cancer Center of Albany Medical Center
  • Albert Einstein Clinical Cancer Center
  • Brooklyn Hospital Center
  • SUNY Downstate Medical Center
  • Brookdale University Hospital and Medical Center
  • Comprehensive Cancer Center at Maimonides Medical Center
  • Roswell Park Cancer Institute
  • North Shore University Hospital
  • Schneider Children's Hospital
  • Memorial Sloan-Kettering Cancer Center
  • New York Weill Cornell Cancer Center at Cornell University
  • Mount Sinai School of Medicine
  • Herbert Irving Comprehensive Cancer Center at Columbia University
  • James P. Wilmot Cancer Center at University of Rochester Medical Center
  • Long Island Cancer Center at Stony Brook University Hospital
  • University Hospital at State University of New York - Upstate Medical University
  • New York Medical College
  • Mission Hospitals
  • Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
  • Blumenthal Cancer Center at Carolinas Medical Center
  • Presbyterian Healthcare
  • Duke Comprehensive Cancer Center
  • Leo W. Jenkins Cancer Center of University Health Systems of Eastern Carolina
  • Comprehensive Cancer Center at Wake Forest University
  • Dakota Cancer Institute at Innovis Health - Dakota Clinic
  • Children's Hospital Medical Center of Akron
  • Cincinnati Children's Hospital Medical Center
  • Ireland Cancer Center
  • Cleveland Clinic Taussig Cancer Center
  • Children's Hospital of Columbus
  • Children's Medical Center - Dayton
  • Toledo Children's Hospital
  • St. Vincent Mercy Medical Center
  • Forum Health-Tod Childrens Hospital
  • Children's Hospital at Oklahoma University Medical Center
  • CCOP - Oklahoma
  • Natalie Warren Bryant Cancer Center
  • CCOP - Columbia River Oncology Program
  • Legacy Emanuel Hospital and Health Center & Children's Hospital
  • Doernbecher Children's Hospital at Oregon Health & Science University
  • Geisinger Medical Center
  • Penn State Cancer Institute at Milton S. Hershey Medical Center
  • Children's Hospital of Philadelphia
  • St. Christopher's Hospital for Children
  • Children's Hospital of Pittsburgh
  • Rhode Island Hospital
  • Hollings Cancer Center at Medical University of South Carolina
  • Palmetto Health South Carolina Cancer Center
  • Children's Hospital of Greenville Hospital System
  • Avera Cancer Institute
  • Sioux Valley Hospital at University of South Dakota Medical Center
  • East Tennessee State University Cancer Center at Johnson City Medical Center
  • East Tennessee Children's Hospital
  • St. Jude Children's Research Hospital
  • Vanderbilt Children's Hospital
  • Texas Tech University Health Sciences Center School of Medicine
  • Children's Hospital of Austin
  • Medical City Dallas Hospital
  • Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas
  • Cook Children's Medical Center - Fort Worth
  • University of Texas Medical Branch
  • University of Texas - MD Anderson Cancer Center
  • Baylor College of Medicine
  • San Antonio Military Pediatric Cancer and Blood Disorders Center
  • Covenant Children's Hospital
  • University of Texas Health Science Center at San Antonio
  • MBCCOP - South Texas Pediatrics
  • Methodist Cancer Center at Methodist Specialty and Transplant Hospital
  • CCOP - Scott and White Hospital
  • Center for Cancer Prevention and Care at Scott and White Clinic
  • Huntsman Cancer Institute
  • Vermont Cancer Center at University of Vermont
  • Cancer Center at the University of Virginia
  • Inova Fairfax Hospital
  • Children's Hospital of the King's Daughters
  • Naval Medical Center, Portsmouth
  • Massey Cancer Center at Virginia Commonwealth University
  • Carilion Medical Center for Children
  • Children's Hospital and Regional Medical Center - Seattle
  • Fred Hutchinson Cancer Research Center
  • Group Health Central Hospital
  • Deaconess Medical Center
  • Mary Bridge Children's Hospital and Health Center
  • Madigan Army Medical Center
  • West Virginia University - Robert C. Byrd Health Sciences Center - Charleston Division
  • Cabell Huntington Hospital
  • West Virginia University Hospitals
  • Bellin Memorial Hospital
  • CCOP - St. Vincent Hospital Cancer Center, Green Bay
  • St. Vincent Hospital
  • Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
  • University of Wisconsin Comprehensive Cancer Center
  • Marshfield Clinic
  • CCOP - Marshfield Clinic Research Foundation
  • Midwest Children's Cancer Center
  • Sydney Children's Hospital
  • Children's Hospital at Westmead
  • Royal Children's Hospital
  • Women's and Children's Hospital
  • Royal Children's Hospital
  • Princess Margaret Hospital for Children
  • Alberta Children's Hospital
  • Cross Cancer Institute
  • British Columbia Children's Hospital
  • CancerCare Manitoba
  • Janeway Children's Health and Rehabilitation Centre
  • IWK Health Centre
  • McMaster Children's Hospital at Hamilton Health Sciences
  • Children's Hospital of Western Ontario
  • Children's Hospital of Eastern Ontario
  • Hospital for Sick Children
  • McGill University Health Center - Montreal Children's Hospital
  • Hopital Sainte Justine
  • Centre de Recherche du Centre Hospitalier de l'Universite Laval
  • Allan Blair Cancer Centre at Pasqua Hospital
  • Saskatoon Cancer Centre
  • Academisch Ziekenhuis Groningen
  • Starship Children's Hospital
  • Puerto Rico Cancer Center at University of Puerto Rico - Medical Sciences Campus
  • San Jorge Childrens Hospital
  • Swiss Pediatric Oncology Group Bern
  • Swiss Pediatric Oncology Group Geneva
  • Swiss Pediatric Oncology Group Lausanne

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Arm A: TMD patients only

Arm B: AML/MDS patients only

Arm Description

Patients are observed if their transient myeloproliferative disorder (TMD) does not require intervention. Patients who require therapy for TMD undergo leukapheresis or exchange transfusion for up to 3 consecutive days. If the TMD does not resolve or there is significant organ involvement, patients receive low-dose cytarabine IV continuously on days 0-4. Treatment repeats at least every 2 weeks for up to 4 courses. Patients who experience a recurrence of TMD at least 8 weeks after resolution or have refractory disease may proceed to group II for further treatment. patients will continue to be followed for remission induction, EFS, DFS and OS regardless of the type of leukemia that develops.

(closed to accrual as of 6/24/04 except for patients first enrolled in group I): Patients receive induction therapy comprising cytarabine IV continuously, daunorubicin hydrochloride IV continuously, and oral thioguanine twice daily on days 0-3. Treatment repeats every 28 days for 4 courses. Patients with no CNS disease at diagnosis receive cytarabine intrathecally (IT) on day 0. Patients with CNS disease at diagnosis receive cytarabine IT on days 0, 5, and 7. If CNS disease persists on day 7, patients receive up to 6 courses of cytarabine IT, therapeutic hydrocortisone IT, and methotrexate IT, twice weekly beginning on day 10. Asparaginase during Intensification 1 day 1 hour 18.

Outcomes

Primary Outcome Measures

Event Free Survival

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
June 26, 2013
Sponsor
Children's Oncology Group
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00003593
Brief Title
Chemotherapy in Treating Children With Down Syndrome and Myeloproliferative Disorder, Acute Myelogenous Leukemia, or Myelodysplastic Syndrome
Official Title
Treatment of Children With Down Syndrome (DS) and Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome (MDS), and Transient Myeloproliferative Disorder (TMD): A Phase III Group-Wide Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
June 1999 (undefined)
Primary Completion Date
March 2007 (Actual)
Study Completion Date
April 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Oncology Group
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase III trial to study the effectiveness of combination chemotherapy in treating children who have Down syndrome and myeloproliferative disorder, acute myelogenous leukemia, or myelodysplastic syndrome.
Detailed Description
OBJECTIVES: Evaluate the efficacy of reduced-dose induction and intensification chemotherapy, in terms of remission rate, disease-free survival rate, and acute morbidity and mortality, in children with Down syndrome and acute myelogenous leukemia or myelodysplastic syndromes. Define the understanding of the natural history of transient myeloproliferative disorder (TMD) in children with Down syndrome. Determine whether there is a reduction of sequelae in long-term survivors after treatment with this regimen. Determine the incidence of subsequent leukemia in patients with transient myeloproliferative disorder treated with this regimen. Determine the predictive risk factors for developing subsequent leukemia in patients with transient myeloproliferative disorder treated with this regimen. OUTLINE: This is a multicenter study. Group I: Patients are observed if their transient myeloproliferative disorder (TMD) does not require intervention. Patients who require therapy for TMD undergo leukapheresis or exchange transfusion for up to 3 consecutive days. If the TMD does not resolve or there is significant organ involvement, patients receive low-dose cytarabine IV continuously on days 0-4. Treatment repeats at least every 2 weeks for up to 4 courses. Patients who experience a recurrence of TMD at least 8 weeks after resolution or have refractory disease may proceed to group II for further treatment. Group II (closed to accrual as of 6/24/04 except for patients first enrolled in group I): Patients receive induction therapy comprising cytarabine IV continuously, daunorubicin IV continuously, and oral thioguanine twice daily on days 0-3. Treatment repeats every 28 days for 4 courses. Patients with no CNS disease at diagnosis receive cytarabine intrathecally (IT) on day 0. Patients with CNS disease at diagnosis receive cytarabine IT on days 0, 5, and 7. If CNS disease persists on day 7, patients receive up to 6 courses of cytarabine IT, hydrocortisone IT, and methotrexate IT, twice weekly beginning on day 10. Patients who achieve remission after induction therapy receive 2 courses of intensification therapy, for approximately 4 months. During the first course, patients receive cytarabine IV over 3 hours twice daily on days 0, 1, 7, and 8. Patients also receive asparaginase intramuscularly on days 1 and 8. The second course of therapy comprises CNS prophylaxis. Patients with no CNS disease at diagnosis or whose CNS disease resolved by day 7 of induction therapy receive cytarabine IT on days 0, 7, and 14. Patients with persistent CNS disease on day 7 of induction therapy receive cytarabine IT, hydrocortisone IT, and methotrexate IT on days 0, 7, and 14. Patients are followed monthly for 18 months, every 3 months for 1 year, every 6 months for 2.5 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 70 patients with acute myeloid leukemia or myelodysplastic syndromes will be accrued for this study within 3.2 years. A total of 88 patients with transient myeloproliferative disorder who enter remission will be accrued for this study within 5 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Neoplasms
Keywords
childhood myelodysplastic syndromes, untreated childhood acute myeloid leukemia and other myeloid malignancies, childhood acute myeloblastic leukemia without maturation (M1), childhood acute myeloblastic leukemia with maturation (M2), childhood acute myelomonocytic leukemia (M4), childhood acute erythroleukemia (M6), childhood acute megakaryocytic leukemia (M7), refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, de novo myelodysplastic syndromes, childhood acute minimally differentiated myeloid leukemia (M0), childhood acute monocytic leukemia (M5b), childhood acute monoblastic leukemia (M5a), myelodysplastic/myeloproliferative neoplasm, unclassifiable, juvenile myelomonocytic leukemia, chronic myelomonocytic leukemia, secondary myelodysplastic syndromes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
254 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm A: TMD patients only
Arm Type
Experimental
Arm Description
Patients are observed if their transient myeloproliferative disorder (TMD) does not require intervention. Patients who require therapy for TMD undergo leukapheresis or exchange transfusion for up to 3 consecutive days. If the TMD does not resolve or there is significant organ involvement, patients receive low-dose cytarabine IV continuously on days 0-4. Treatment repeats at least every 2 weeks for up to 4 courses. Patients who experience a recurrence of TMD at least 8 weeks after resolution or have refractory disease may proceed to group II for further treatment. patients will continue to be followed for remission induction, EFS, DFS and OS regardless of the type of leukemia that develops.
Arm Title
Arm B: AML/MDS patients only
Arm Type
Experimental
Arm Description
(closed to accrual as of 6/24/04 except for patients first enrolled in group I): Patients receive induction therapy comprising cytarabine IV continuously, daunorubicin hydrochloride IV continuously, and oral thioguanine twice daily on days 0-3. Treatment repeats every 28 days for 4 courses. Patients with no CNS disease at diagnosis receive cytarabine intrathecally (IT) on day 0. Patients with CNS disease at diagnosis receive cytarabine IT on days 0, 5, and 7. If CNS disease persists on day 7, patients receive up to 6 courses of cytarabine IT, therapeutic hydrocortisone IT, and methotrexate IT, twice weekly beginning on day 10. Asparaginase during Intensification 1 day 1 hour 18.
Intervention Type
Drug
Intervention Name(s)
asparaginase
Other Intervention Name(s)
Elspar, Kidrolase, Crasnitin, Leunase, NSC #109229
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
cytarabine
Other Intervention Name(s)
cytosine arabinoside, AraC, Cytosar, NSC #063878
Intervention Description
Given IT
Intervention Type
Drug
Intervention Name(s)
daunorubicin hydrochloride
Other Intervention Name(s)
daunomycin, DNR, Cerubidine, NSC #82151
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
methotrexate
Other Intervention Name(s)
MTX, amethopterin, NSC #000740
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
therapeutic hydrocortisone
Other Intervention Name(s)
Cortef, Solu-cortef, NSC #010483
Intervention Description
Given IT
Intervention Type
Drug
Intervention Name(s)
thioguanine
Other Intervention Name(s)
6-thioguanine, 6-TG, NSC # 000752
Intervention Description
Given IV
Primary Outcome Measure Information:
Title
Event Free Survival
Time Frame
Length of study

10. Eligibility

Sex
All
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Cytogenetically proven Down Syndrome (constitutional trisomy 21) with transient myeloproliferative disorder (TMD), myelodysplastic syndromes (MDS), or acute myelogenous leukemia (AML) Must be confirmed by bone marrow aspirate, cerebrospinal fluid exam, or blood test Trisomy 21 mosaicism allowed Group I: Diagnosis of TMD in patients no older than 90 days at initial presentation Must have nonerythroid blasts (any amount) in the peripheral blood and one of the following: Verification with a second sample More than 5% bone marrow blasts Hepatomegaly and/or splenomegaly Lymphadenopathy Cardiac or pleural effusions OR Histologically or cytologically proven TMD with blasts in an affected organ or in fluid (pericardial, pleural, or peritoneal) Bone marrow aspirate is required Group II (closed to accrual as of 6/24/04): Diagnosis of MDS or AML (except M3 subtype) in patients older than 90 days with more than 29% blasts in bone marrow (with or without history of TMD), or any of the following histologies: Refractory anemia (RA) RA with excess blasts (RAEB) RAEB in transformation RA with ringed sideroblasts (RARS) Primary cytopenia (later confirmed by bone marrow aspirate as due to marrow hypoplasia) defined by one or more of the following: Absolute neutrophil count less than 500/mm^3 Untransfused platelet count less than 30,000/mm^3 Untransfused hemoglobin less than 8 g/dL The following diagnoses will be observed only: RA with mild cytopenias* RARS with mild cytopenias* Mild primary cytopenias (one or more) without dysplasia (confirmed by hypoplastic bone marrow exam) NOTE: * Platelet count 30-150,000/mm3, absolute neutrophil count 500-1,499/mm3, and hemoglobin greater than 8 g/dL Granulocytic sarcoma (chloroma), with or without bone marrow involvement, allowed PATIENT CHARACTERISTICS: Age: See Disease Characteristics 21 and under Performance status: Not specified Life expectancy: Not specified Hematopoietic: See Disease Characteristics Hepatic: See Disease Characteristics Renal: Not specified Cardiovascular: Shortening fraction greater than 27% by echocardiogram* OR Ejection fraction greater than 47% by radionuclide angiogram* NOTE: *For patients with MDS and AML (as of 2/24/04, previously diagnosed MDS or AML closed to accrual; MDS or AML that develops (secondary to TMD) after study enrollment or MDS that requires initial observation [with or without subsequent treatment] allowed) PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Prior chemotherapy for TMD allowed No prior chemotherapy for malignancy Endocrine therapy: Concurrent topical or inhaled steroids for other conditions allowed Radiotherapy: No prior radiotherapy for malignancy Surgery: Not specified Other: No prior antileukemic therapy Prior enrollment on this study for TMD allowed
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alan S. Gamis, MD, MPH
Organizational Affiliation
Children's Mercy Hospital Kansas City
Official's Role
Study Chair
Facility Information:
Facility Name
University of Alabama at Birmingham Comprehensive Cancer Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
University of South Alabama Cancer Research Institute
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36604
Country
United States
Facility Name
Phoenix Children's Hospital
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016-7710
Country
United States
Facility Name
Arizona Cancer Center at University of Arizona Health Sciences Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Southern California Permanente Medical Group
City
Downey
State/Province
California
ZIP/Postal Code
90242
Country
United States
Facility Name
City of Hope Comprehensive Cancer Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010-3000
Country
United States
Facility Name
Rebecca and John Moores UCSD Cancer Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92093-0658
Country
United States
Facility Name
Loma Linda University Cancer Institute at Loma Linda University Medical Center
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
Facility Name
Jonathan Jaques Children's Cancer Center at Miller Children's Hospital
City
Long Beach
State/Province
California
ZIP/Postal Code
90801-1428
Country
United States
Facility Name
Children's Hospital Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027-0700
Country
United States
Facility Name
Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Jonsson Comprehensive Cancer Center, UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-1781
Country
United States
Facility Name
Children's Hospital Central California
City
Madera
State/Province
California
ZIP/Postal Code
93638-8762
Country
United States
Facility Name
Children's Hospital and Research Center at Oakland
City
Oakland
State/Province
California
ZIP/Postal Code
94609-1809
Country
United States
Facility Name
Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Children's Hospital of Orange County
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Lucile Packard Children's Hospital at Stanford University Medical Center
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
Sutter Cancer Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95816
Country
United States
Facility Name
University of California Davis Cancer Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Kaiser Permanente Medical Center - Sacramento
City
Sacramento
State/Province
California
ZIP/Postal Code
95825
Country
United States
Facility Name
Kaiser Permanente Medical Center/Kaiser Foundation Hospital - San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92120
Country
United States
Facility Name
Children's Hospital and Health Center, San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92123-4282
Country
United States
Facility Name
UCSF Comprehensive Cancer Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Santa Barbara Cottage Hospital
City
Santa Barbara
State/Province
California
ZIP/Postal Code
93102
Country
United States
Facility Name
Kaiser Permanente Medical Center - Santa Clara
City
Santa Clara
State/Province
California
ZIP/Postal Code
95051-5386
Country
United States
Facility Name
David Grant Medical Center
City
Travis Air Force Base
State/Province
California
ZIP/Postal Code
94535
Country
United States
Facility Name
Children's Hospital of Denver
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218-1088
Country
United States
Facility Name
Presbyterian - St. Luke's Medical Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
University of Connecticut Comprehensive Cancer Center at University of Connecticut Health Center
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06360-7106
Country
United States
Facility Name
Yale Comprehensive Cancer Center
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520-8028
Country
United States
Facility Name
Alfred I. duPont Hospital for Children
City
Wilmington
State/Province
Delaware
ZIP/Postal Code
19899
Country
United States
Facility Name
Lombardi Cancer Center at Georgetown University Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Children's National Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010-2970
Country
United States
Facility Name
Walter Reed Army Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20307-5001
Country
United States
Facility Name
Broward General Medical Center
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33316
Country
United States
Facility Name
Children's Hospital of Southwest Florida
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33908
Country
United States
Facility Name
Shands Cancer Center at the University of Florida Health Science Center
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610-0296
Country
United States
Facility Name
Joe DiMaggio Children's Hospital at Memorial
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
Nemours Children's Clinic
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
Jackson Memorial Hospital
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Miami Children's Hospital
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Facility Name
Baptist Hospital of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33176-2197
Country
United States
Facility Name
Florida Hospital Cancer Institute
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
Facility Name
Nemours Children's Clinic-Orlando
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Sacred Heart Children's Hospital
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32504
Country
United States
Facility Name
All Children's Hospital
City
St. Petersburg
State/Province
Florida
ZIP/Postal Code
33701
Country
United States
Facility Name
St. Joseph's Children's Hospital
City
Tampa
State/Province
Florida
ZIP/Postal Code
33677-4227
Country
United States
Facility Name
St. Mary's Hospital
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
Facility Name
AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Scottish RiteCampus
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
MBCCOP-Medical College of Georgia Cancer Center
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912-4000
Country
United States
Facility Name
Medical Center of Central Georgia
City
Macon
State/Province
Georgia
ZIP/Postal Code
31201
Country
United States
Facility Name
Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31405
Country
United States
Facility Name
Cancer Research Center of Hawaii
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
Facility Name
MBCCOP - Hawaii
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
Facility Name
Tripler Army Medical Center
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96859-5000
Country
United States
Facility Name
Mountain States Tumor Institute - Boise
City
Boise
State/Province
Idaho
ZIP/Postal Code
83712
Country
United States
Facility Name
University of Chicago Cancer Research Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60601
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
University of Illinois Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Children's Memorial Hospital - Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60614
Country
United States
Facility Name
Advocate Hope Children's Hospital
City
Oak Lawn
State/Province
Illinois
ZIP/Postal Code
60453
Country
United States
Facility Name
Lutheran General Cancer Care Center
City
Park Ridge
State/Province
Illinois
ZIP/Postal Code
60068-1174
Country
United States
Facility Name
Saint Jude Midwest Affiliate
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61637
Country
United States
Facility Name
Southern Illinois University School of Medicine
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62794-9658
Country
United States
Facility Name
Riley Children Cancer Center at Riley Hospital for Children
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202-5225
Country
United States
Facility Name
St. Vincent Hospital and Health Care Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
Blank Children's Hospital
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50308
Country
United States
Facility Name
John Stoddard Cancer Center at Iowa Methodist Medical Center
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50309
Country
United States
Facility Name
Holden Comprehensive Cancer Center at University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242-1009
Country
United States
Facility Name
Wesley Medical Center
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
Markey Cancer Center at University of Kentucky Chandler Medical Center
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536-0284
Country
United States
Facility Name
Kosair Children's Hospital
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202-3830
Country
United States
Facility Name
MBCCOP - LSU Health Sciences Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Tulane Cancer Center at Tulane University Hospital and Clinic
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Children's Hospital of New Orleans
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70118
Country
United States
Facility Name
Ochsner Clinic Foundation
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
Eastern Maine Medical Center
City
Bangor
State/Province
Maine
ZIP/Postal Code
04401
Country
United States
Facility Name
Maine Children's Cancer Program
City
Scarborough
State/Province
Maine
ZIP/Postal Code
04074-9308
Country
United States
Facility Name
Greenebaum Cancer Center at University of Maryland Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201-1595
Country
United States
Facility Name
Sinai Hospital of Baltimore
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21225
Country
United States
Facility Name
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231-2410
Country
United States
Facility Name
Floating Hospital for Children
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Baystate Regional Cancer Program at Baystate Medical Center
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01107
Country
United States
Facility Name
University of Massachusetts Memorial Medical Center - University Campus
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
University of Michigan Comprehensive Cancer Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-0914
Country
United States
Facility Name
Children's Hospital of Michigan
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Josephine Ford Cancer Center at Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Van Elslander Cancer Center at St. John Hospital and Medical Center
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48236
Country
United States
Facility Name
Hurley Medical Center
City
Flint
State/Province
Michigan
ZIP/Postal Code
48503
Country
United States
Facility Name
Spectrum Health and DeVos Children's Hospital
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
Bronson Methodist Hospital
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49007-5364
Country
United States
Facility Name
Breslin Cancer Center at Ingham Regional Medical Center
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48910
Country
United States
Facility Name
CCOP - Beaumont
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073-6769
Country
United States
Facility Name
William Beaumont Hospital - Royal Oak
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073-6769
Country
United States
Facility Name
St. Mary's - Duluth Clinic Cancer Center
City
Duluth
State/Province
Minnesota
ZIP/Postal Code
55805
Country
United States
Facility Name
Children's Hospitals and Clinics - Minneapolis
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States
Facility Name
Mayo Clinic Cancer Center
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Children's Hospitals and Clinics - Minnesota
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55102
Country
United States
Facility Name
University of Mississippi Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216-4505
Country
United States
Facility Name
Children's Mercy Hospital
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
Facility Name
Cardinal Glennon Children's Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63104
Country
United States
Facility Name
St. Louis Children's Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Children's Hospital of Omaha
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
UNMC Eppley Cancer Center at the University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198-2168
Country
United States
Facility Name
Sunrise Hospital and Medical Center
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89109
Country
United States
Facility Name
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
Cancer Center at Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Cancer Institute of New Jersey at Robert Wood Johnson University Hospital
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
Facility Name
Newark Beth Israel Medical Center
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07112-2094
Country
United States
Facility Name
St. Joseph's Hospital and Medical Center
City
Paterson
State/Province
New Jersey
ZIP/Postal Code
07503
Country
United States
Facility Name
Valerie Fund Children's Center at Atlantic Health
City
Summit
State/Province
New Jersey
ZIP/Postal Code
07901
Country
United States
Facility Name
University of New Mexico Cancer Research and Treatment Center
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
Facility Name
Cancer Center of Albany Medical Center
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Albert Einstein Clinical Cancer Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
Brooklyn Hospital Center
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11201-5493
Country
United States
Facility Name
SUNY Downstate Medical Center
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203
Country
United States
Facility Name
Brookdale University Hospital and Medical Center
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11212
Country
United States
Facility Name
Comprehensive Cancer Center at Maimonides Medical Center
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11219
Country
United States
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263-0001
Country
United States
Facility Name
North Shore University Hospital
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
Schneider Children's Hospital
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
New York Weill Cornell Cancer Center at Cornell University
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Mount Sinai School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Herbert Irving Comprehensive Cancer Center at Columbia University
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
James P. Wilmot Cancer Center at University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Long Island Cancer Center at Stony Brook University Hospital
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Facility Name
University Hospital at State University of New York - Upstate Medical University
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
New York Medical College
City
Valhalla
State/Province
New York
ZIP/Postal Code
10595
Country
United States
Facility Name
Mission Hospitals
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28801
Country
United States
Facility Name
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7295
Country
United States
Facility Name
Blumenthal Cancer Center at Carolinas Medical Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28232-2861
Country
United States
Facility Name
Presbyterian Healthcare
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28233
Country
United States
Facility Name
Duke Comprehensive Cancer Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Leo W. Jenkins Cancer Center of University Health Systems of Eastern Carolina
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27858-4354
Country
United States
Facility Name
Comprehensive Cancer Center at Wake Forest University
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157-1081
Country
United States
Facility Name
Dakota Cancer Institute at Innovis Health - Dakota Clinic
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58103-4940
Country
United States
Facility Name
Children's Hospital Medical Center of Akron
City
Akron
State/Province
Ohio
ZIP/Postal Code
44308
Country
United States
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229-3039
Country
United States
Facility Name
Ireland Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106-5065
Country
United States
Facility Name
Cleveland Clinic Taussig Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Children's Hospital of Columbus
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205-2696
Country
United States
Facility Name
Children's Medical Center - Dayton
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45404
Country
United States
Facility Name
Toledo Children's Hospital
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43601
Country
United States
Facility Name
St. Vincent Mercy Medical Center
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43608
Country
United States
Facility Name
Forum Health-Tod Childrens Hospital
City
Youngstown
State/Province
Ohio
ZIP/Postal Code
44501
Country
United States
Facility Name
Children's Hospital at Oklahoma University Medical Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
CCOP - Oklahoma
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136
Country
United States
Facility Name
Natalie Warren Bryant Cancer Center
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136
Country
United States
Facility Name
CCOP - Columbia River Oncology Program
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Facility Name
Legacy Emanuel Hospital and Health Center & Children's Hospital
City
Portland
State/Province
Oregon
ZIP/Postal Code
97227
Country
United States
Facility Name
Doernbecher Children's Hospital at Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239-3098
Country
United States
Facility Name
Geisinger Medical Center
City
Danville
State/Province
Pennsylvania
ZIP/Postal Code
17822-1320
Country
United States
Facility Name
Penn State Cancer Institute at Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
St. Christopher's Hospital for Children
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19134-1095
Country
United States
Facility Name
Children's Hospital of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213-2583
Country
United States
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
Hollings Cancer Center at Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425-0721
Country
United States
Facility Name
Palmetto Health South Carolina Cancer Center
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29203
Country
United States
Facility Name
Children's Hospital of Greenville Hospital System
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
Avera Cancer Institute
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57105-1080
Country
United States
Facility Name
Sioux Valley Hospital at University of South Dakota Medical Center
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57117-5039
Country
United States
Facility Name
East Tennessee State University Cancer Center at Johnson City Medical Center
City
Johnson City
State/Province
Tennessee
ZIP/Postal Code
37604
Country
United States
Facility Name
East Tennessee Children's Hospital
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37901
Country
United States
Facility Name
St. Jude Children's Research Hospital
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38105-2794
Country
United States
Facility Name
Vanderbilt Children's Hospital
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-6310
Country
United States
Facility Name
Texas Tech University Health Sciences Center School of Medicine
City
Amarillo
State/Province
Texas
ZIP/Postal Code
79106
Country
United States
Facility Name
Children's Hospital of Austin
City
Austin
State/Province
Texas
ZIP/Postal Code
78701
Country
United States
Facility Name
Medical City Dallas Hospital
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-9063
Country
United States
Facility Name
Cook Children's Medical Center - Fort Worth
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
University of Texas Medical Branch
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555-0361
Country
United States
Facility Name
University of Texas - MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4009
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
San Antonio Military Pediatric Cancer and Blood Disorders Center
City
Lackland Air Force Base
State/Province
Texas
ZIP/Postal Code
78236
Country
United States
Facility Name
Covenant Children's Hospital
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79410
Country
United States
Facility Name
University of Texas Health Science Center at San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78207
Country
United States
Facility Name
MBCCOP - South Texas Pediatrics
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229-3900
Country
United States
Facility Name
Methodist Cancer Center at Methodist Specialty and Transplant Hospital
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229-3902
Country
United States
Facility Name
CCOP - Scott and White Hospital
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States
Facility Name
Center for Cancer Prevention and Care at Scott and White Clinic
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States
Facility Name
Huntsman Cancer Institute
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Facility Name
Vermont Cancer Center at University of Vermont
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401-3498
Country
United States
Facility Name
Cancer Center at the University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Inova Fairfax Hospital
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22042-3300
Country
United States
Facility Name
Children's Hospital of the King's Daughters
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
Naval Medical Center, Portsmouth
City
Portsmouth
State/Province
Virginia
ZIP/Postal Code
23708-5100
Country
United States
Facility Name
Massey Cancer Center at Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298-0121
Country
United States
Facility Name
Carilion Medical Center for Children
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24029
Country
United States
Facility Name
Children's Hospital and Regional Medical Center - Seattle
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Facility Name
Fred Hutchinson Cancer Research Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109-1024
Country
United States
Facility Name
Group Health Central Hospital
City
Seattle
State/Province
Washington
ZIP/Postal Code
98112
Country
United States
Facility Name
Deaconess Medical Center
City
Spokane
State/Province
Washington
ZIP/Postal Code
99210-0248
Country
United States
Facility Name
Mary Bridge Children's Hospital and Health Center
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98415-0299
Country
United States
Facility Name
Madigan Army Medical Center
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98431-5000
Country
United States
Facility Name
West Virginia University - Robert C. Byrd Health Sciences Center - Charleston Division
City
Charleston
State/Province
West Virginia
ZIP/Postal Code
25302
Country
United States
Facility Name
Cabell Huntington Hospital
City
Huntington
State/Province
West Virginia
ZIP/Postal Code
25701
Country
United States
Facility Name
West Virginia University Hospitals
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506-9300
Country
United States
Facility Name
Bellin Memorial Hospital
City
Green Bay
State/Province
Wisconsin
ZIP/Postal Code
54301
Country
United States
Facility Name
CCOP - St. Vincent Hospital Cancer Center, Green Bay
City
Green Bay
State/Province
Wisconsin
ZIP/Postal Code
54301
Country
United States
Facility Name
St. Vincent Hospital
City
Green Bay
State/Province
Wisconsin
ZIP/Postal Code
54307-9070
Country
United States
Facility Name
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
City
La Crosse
State/Province
Wisconsin
ZIP/Postal Code
54601
Country
United States
Facility Name
University of Wisconsin Comprehensive Cancer Center
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792-6164
Country
United States
Facility Name
Marshfield Clinic
City
Marshfield
State/Province
Wisconsin
ZIP/Postal Code
54449-5772
Country
United States
Facility Name
CCOP - Marshfield Clinic Research Foundation
City
Marshfield
State/Province
Wisconsin
ZIP/Postal Code
54449
Country
United States
Facility Name
Midwest Children's Cancer Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Sydney Children's Hospital
City
Randwick
State/Province
New South Wales
ZIP/Postal Code
2031
Country
Australia
Facility Name
Children's Hospital at Westmead
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
Royal Children's Hospital
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
Facility Name
Women's and Children's Hospital
City
North Adelaide
State/Province
South Australia
ZIP/Postal Code
5006
Country
Australia
Facility Name
Royal Children's Hospital
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3052
Country
Australia
Facility Name
Princess Margaret Hospital for Children
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6001
Country
Australia
Facility Name
Alberta Children's Hospital
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2T 5C7
Country
Canada
Facility Name
Cross Cancer Institute
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Facility Name
British Columbia Children's Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6H 3V4
Country
Canada
Facility Name
CancerCare Manitoba
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E 0V9
Country
Canada
Facility Name
Janeway Children's Health and Rehabilitation Centre
City
St. John's
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1B 3V6
Country
Canada
Facility Name
IWK Health Centre
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3J 3G9
Country
Canada
Facility Name
McMaster Children's Hospital at Hamilton Health Sciences
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 3Z5
Country
Canada
Facility Name
Children's Hospital of Western Ontario
City
London
State/Province
Ontario
ZIP/Postal Code
N6C 2V5
Country
Canada
Facility Name
Children's Hospital of Eastern Ontario
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L1
Country
Canada
Facility Name
Hospital for Sick Children
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X8
Country
Canada
Facility Name
McGill University Health Center - Montreal Children's Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3G 1A4
Country
Canada
Facility Name
Hopital Sainte Justine
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1C5
Country
Canada
Facility Name
Centre de Recherche du Centre Hospitalier de l'Universite Laval
City
Sainte Foy
State/Province
Quebec
ZIP/Postal Code
GIV 4G2
Country
Canada
Facility Name
Allan Blair Cancer Centre at Pasqua Hospital
City
Regina
State/Province
Saskatchewan
ZIP/Postal Code
S4T 7T1
Country
Canada
Facility Name
Saskatoon Cancer Centre
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7N 4H4
Country
Canada
Facility Name
Academisch Ziekenhuis Groningen
City
Groningen
ZIP/Postal Code
9700 RB
Country
Netherlands
Facility Name
Starship Children's Hospital
City
Auckland
Country
New Zealand
Facility Name
Puerto Rico Cancer Center at University of Puerto Rico - Medical Sciences Campus
City
San Juan
ZIP/Postal Code
00936-5067
Country
Puerto Rico
Facility Name
San Jorge Childrens Hospital
City
Santurce
ZIP/Postal Code
00912
Country
Puerto Rico
Facility Name
Swiss Pediatric Oncology Group Bern
City
Bern
ZIP/Postal Code
CH 3010
Country
Switzerland
Facility Name
Swiss Pediatric Oncology Group Geneva
City
Geneva
ZIP/Postal Code
CH 1211
Country
Switzerland
Facility Name
Swiss Pediatric Oncology Group Lausanne
City
Lausanne
ZIP/Postal Code
CH 1011
Country
Switzerland

12. IPD Sharing Statement

Citations:
Citation
Perentesis JP, Alonzo TA, Gerbing R, et al.: Polymorphism in folate metabolism and outcomes of therapy in children with AML with and without Down Syndrome. [Abstract] Blood 102 (11 Pt 1): A-479, 2003.
Results Reference
background
PubMed Identifier
22392565
Citation
Sorrell AD, Alonzo TA, Hilden JM, Gerbing RB, Loew TW, Hathaway L, Barnard D, Taub JW, Ravindranath Y, Smith FO, Arceci RJ, Woods WG, Gamis AS. Favorable survival maintained in children who have myeloid leukemia associated with Down syndrome using reduced-dose chemotherapy on Children's Oncology Group trial A2971: a report from the Children's Oncology Group. Cancer. 2012 Oct 1;118(19):4806-14. doi: 10.1002/cncr.27484. Epub 2012 Mar 5.
Results Reference
result
PubMed Identifier
21849481
Citation
Gamis AS, Alonzo TA, Gerbing RB, Hilden JM, Sorrell AD, Sharma M, Loew TW, Arceci RJ, Barnard D, Doyle J, Massey G, Perentesis J, Ravindranath Y, Taub J, Smith FO. Natural history of transient myeloproliferative disorder clinically diagnosed in Down syndrome neonates: a report from the Children's Oncology Group Study A2971. Blood. 2011 Dec 22;118(26):6752-9; quiz 6996. doi: 10.1182/blood-2011-04-350017. Epub 2011 Aug 17.
Results Reference
result
Citation
Gamis AS, Alonzo TA, Hilden JM, et al.: Outcome of Down syndrome (DS) children with acute myeloid leukemia (AML) or myelodysplasia (MDS) treated with a uniform prospective clinical trial initial report of the COG trial A2971. [Abstract] Blood 108 (11): A-15, 2006.
Results Reference
result
Citation
Sharma M, Alonzo TA, Sorrell A, et al.: Uniform approach better defines natural history of transient myeloproliferative disorder (TMD) in Down syndrome (DS) neonates: outcomes from Children's Oncology Group (COG) study A2971. [Abstract] Blood 108 (11): A-376, 2006.
Results Reference
result

Learn more about this trial

Chemotherapy in Treating Children With Down Syndrome and Myeloproliferative Disorder, Acute Myelogenous Leukemia, or Myelodysplastic Syndrome

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