Back to resultsArsenic Trioxide in Treating Young Patients With Refractory Leukemia or Lymphoma
Primary Purpose
Leukemia, Lymphoma
Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
arsenic trioxide
Sponsored by
About this trial
This is an interventional treatment trial for Leukemia focused on measuring recurrent childhood acute myeloid leukemia, childhood acute promyelocytic leukemia (M3), recurrent childhood acute lymphoblastic leukemia, recurrent childhood large cell lymphoma, recurrent childhood lymphoblastic lymphoma, recurrent childhood small noncleaved cell lymphoma, recurrent/refractory childhood Hodgkin lymphoma, childhood chronic myelogenous leukemia, atypical chronic myeloid leukemia, BCR-ABL1 negative
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed leukemia or lymphoma refractory to standard curative treatment regimens Measurable or evaluable disease No meningeal leukemia or lymphoma No HIV-related lymphoma No lymphoproliferative diseases PATIENT CHARACTERISTICS: Age: 2 to 21 Acute promyelocytic leukemia (APL) patients (stratum I) must be age 2 to 12 Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin normal SGPT less than 2 times upper limit of normal No significant hepatic dysfunction that would preclude study therapy Renal: Creatinine normal (age adjusted) OR Creatinine clearance at least 60 mL/min Potassium, magnesium, and calcium at least lower limit of normal (oral or IV supplementation allowed) No significant renal dysfunction that would preclude study therapy Cardiovascular: Rate corrected QTc interval no greater than 0.48 on EKG No significant cardiac dysfunction that would preclude study therapy No cardiac disease, including dysrhythmias Pulmonary: No significant pulmonary dysfunction that would preclude study therapy Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No persistent grade 3 or greater sensory or motor neuropathy No prior grand mal seizures (grade 3 or greater) within the past 2 years other than febrile seizures (except for patients with APL at discretion of investigator) No clinically significant unrelated systemic illness that would preclude study therapy (e.g., serious infection) HIV negative PRIOR CONCURRENT THERAPY: Biologic therapy: At least 1 week since prior colony-stimulating factors (e.g., filgrastim [G-CSF], sargramostim [GM-CSF], and epoetin alfa) No concurrent immunotherapy Chemotherapy: No prior arsenic trioxide At least 2 weeks since prior chemotherapy (4 weeks for nitrosoureas) and recovered No concurrent intrathecal chemotherapy except for acute promyelocytic leukemia (APL) patients experiencing progressive meningeal leukemia and demonstrating benefit from arsenic trioxide for systemic disease No other concurrent anticancer chemotherapy Endocrine therapy: No concurrent steroids (except corticosteroids for retinoic acid syndrome) Radiotherapy: At least 4 weeks since prior radiotherapy and recovered No concurrent radiotherapy Surgery: Not specified Other: At least 6 months since prior anticonvulsants At least 1 week since prior retinoid therapy No concurrent retinoids No other concurrent investigational agents
Sites / Locations
- Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
- City of Hope Comprehensive Cancer Center
- Rebecca and John Moores UCSD Cancer Center
- Children's Hospital Los Angeles
- Jonsson Comprehensive Cancer Center, UCLA
- Children's Hospital of Orange County
- Lucile Packard Children's Hospital at Stanford University Medical Center
- UCSF Comprehensive Cancer Center
- County of Los Angeles Harbor-UCLA Medical Center
- Children's National Medical Center
- AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Scottish Rite Campus
- Children's Memorial Hospital - Chicago
- Riley Children Cancer Center at Riley Hospital for Children
- Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
- Floating Hospital for Children
- Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
- University of Michigan Comprehensive Cancer Center
- Children's Hospital of Michigan
- Mayo Clinic Cancer Center
- University of Mississippi Medical Center
- Children's Mercy Hospital
- Cardinal Glennon Children's Hospital
- St. Louis Children's Hospital
- Cancer Center at Hackensack University Medical Center
- NYU School of Medicine's Kaplan Comprehensive Cancer Center
- Memorial Sloan-Kettering Cancer Center
- Herbert Irving Comprehensive Cancer Center at Columbia University
- SUNY Upstate Medical University Hospital
- Duke Comprehensive Cancer Center
- Cincinnati Children's Hospital Medical Center
- Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University
- Oklahoma University Medical Center
- Children's Hospital of Philadelphia
- Children's Hospital of Pittsburgh
- St. Jude Children's Research Hospital
- Vanderbilt Children's Hospital
- Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas
- Cook Children's Medical Center - Fort Worth
- Texas Children's Cancer Center
- MD Anderson Cancer Center at University of Texas
- University of Texas Health Science Center at San Antonio
- Huntsman Cancer Institute at University of Utah
- Children's Hospital and Regional Medical Center - Seattle
- University of Wisconsin Comprehensive Cancer Center
- Midwest Children's Cancer Center
- Royal Children's Hospital
- Princess Margaret Hospital for Children
- Hospital for Sick Children
- Montreal Children's Hospital at McGill University Health Center
- Hopital Sainte Justine
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00020111
First Posted
July 11, 2001
Last Updated
April 28, 2015
Sponsor
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT00020111
Brief Title
Arsenic Trioxide in Treating Young Patients With Refractory Leukemia or Lymphoma
Official Title
Phase I Trial and Pharmacokinetic Study of Arsenic Trioxide in Pediatric Patients With Refractory Leukemia or Lymphoma
Study Type
Interventional
2. Study Status
Record Verification Date
February 2005
Overall Recruitment Status
Completed
Study Start Date
March 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Cancer Institute (NCI)
4. Oversight
5. Study Description
Brief Summary
RATIONALE: Drugs used in chemotherapy work in different ways to stop cancer cells from dividing so they stop growing or die.
PURPOSE: This phase I trial is studying the side effects and best dose of arsenic trioxide in treating young patients with leukemia or lymphoma.
Detailed Description
OBJECTIVES:
Determine the toxic effects of arsenic trioxide in pediatric patients with refractory leukemia or lymphoma.
Determine the maximum tolerated dose of this drug in this patient population.
Determine the plasma pharmacokinetics of this drug in these patients.
OUTLINE: This is a dose-escalation, multicenter study. Patients are stratified according to disease (acute promyelocytic leukemia [APL] vs non-APL).
Stratum I (APL patients): Patients receive standard-dose arsenic trioxide IV over 2 hours daily 5 days a week for 4 weeks. Treatment continues every 6 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity.
Stratum II (Non-APL patients): Cohorts of 3-6 patients receive escalating doses of arsenic trioxide (according to the stratum 1 schedule above) until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, additional patients are accrued to receive treatment with arsenic trioxide at the recommended phase II dose.
Leukemia patients in both strata without progressive disease who have not achieved complete remission after the first 20 doses may continue to receive arsenic trioxide for 2 additional weeks.
Patients are followed every 3 months for 1 year.
PROJECTED ACCRUAL: A maximum of 18 patients will be accrued for stratum I of this study within 2-3 years. A total of 3-30 patients will be accrued for stratum II of this study within 1-2 years.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia, Lymphoma
Keywords
recurrent childhood acute myeloid leukemia, childhood acute promyelocytic leukemia (M3), recurrent childhood acute lymphoblastic leukemia, recurrent childhood large cell lymphoma, recurrent childhood lymphoblastic lymphoma, recurrent childhood small noncleaved cell lymphoma, recurrent/refractory childhood Hodgkin lymphoma, childhood chronic myelogenous leukemia, atypical chronic myeloid leukemia, BCR-ABL1 negative
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
arsenic trioxide
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically confirmed leukemia or lymphoma refractory to standard curative treatment regimens
Measurable or evaluable disease
No meningeal leukemia or lymphoma
No HIV-related lymphoma
No lymphoproliferative diseases
PATIENT CHARACTERISTICS:
Age:
2 to 21
Acute promyelocytic leukemia (APL) patients (stratum I) must be age 2 to 12
Performance status:
ECOG 0-2
Life expectancy:
Not specified
Hematopoietic:
Not specified
Hepatic:
Bilirubin normal
SGPT less than 2 times upper limit of normal
No significant hepatic dysfunction that would preclude study therapy
Renal:
Creatinine normal (age adjusted) OR
Creatinine clearance at least 60 mL/min
Potassium, magnesium, and calcium at least lower limit of normal (oral or IV supplementation allowed)
No significant renal dysfunction that would preclude study therapy
Cardiovascular:
Rate corrected QTc interval no greater than 0.48 on EKG
No significant cardiac dysfunction that would preclude study therapy
No cardiac disease, including dysrhythmias
Pulmonary:
No significant pulmonary dysfunction that would preclude study therapy
Other:
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No persistent grade 3 or greater sensory or motor neuropathy
No prior grand mal seizures (grade 3 or greater) within the past 2 years other than febrile seizures (except for patients with APL at discretion of investigator)
No clinically significant unrelated systemic illness that would preclude study therapy (e.g., serious infection)
HIV negative
PRIOR CONCURRENT THERAPY:
Biologic therapy:
At least 1 week since prior colony-stimulating factors (e.g., filgrastim [G-CSF], sargramostim [GM-CSF], and epoetin alfa)
No concurrent immunotherapy
Chemotherapy:
No prior arsenic trioxide
At least 2 weeks since prior chemotherapy (4 weeks for nitrosoureas) and recovered
No concurrent intrathecal chemotherapy except for acute promyelocytic leukemia (APL) patients experiencing progressive meningeal leukemia and demonstrating benefit from arsenic trioxide for systemic disease
No other concurrent anticancer chemotherapy
Endocrine therapy:
No concurrent steroids (except corticosteroids for retinoic acid syndrome)
Radiotherapy:
At least 4 weeks since prior radiotherapy and recovered
No concurrent radiotherapy
Surgery:
Not specified
Other:
At least 6 months since prior anticonvulsants
At least 1 week since prior retinoid therapy
No concurrent retinoids
No other concurrent investigational agents
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frank M. Balis, MD
Organizational Affiliation
National Cancer Institute (NCI)
Official's Role
Study Chair
Facility Information:
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
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
92103-8447
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
Jonsson Comprehensive Cancer Center, UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-1781
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
UCSF Comprehensive Cancer Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
County of Los Angeles Harbor-UCLA Medical Center
City
Torrance
State/Province
California
ZIP/Postal Code
90509
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
AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Scottish Rite Campus
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Children's Memorial Hospital - Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60614
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
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160-7357
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
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892-1182
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
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
Mayo Clinic Cancer Center
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
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
Cancer Center at Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
NYU School of Medicine's Kaplan Comprehensive Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
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
Herbert Irving Comprehensive Cancer Center at Columbia University
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
SUNY Upstate Medical University Hospital
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Duke Comprehensive Cancer Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229-2899
Country
United States
Facility Name
Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106-5065
Country
United States
Facility Name
Oklahoma University Medical Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73126
Country
United States
Facility Name
Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Children's Hospital of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
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
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
Texas Children's Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-2399
Country
United States
Facility Name
MD Anderson Cancer Center at University of Texas
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4009
Country
United States
Facility Name
University of Texas Health Science Center at San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78284-7811
Country
United States
Facility Name
Huntsman Cancer Institute at University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
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
University of Wisconsin Comprehensive Cancer Center
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792-6164
Country
United States
Facility Name
Midwest Children's Cancer Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
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
Hospital for Sick Children
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X8
Country
Canada
Facility Name
Montreal Children's Hospital at McGill University Health Center
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3H 1P3
Country
Canada
Facility Name
Hopital Sainte Justine
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1C5
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
17959855
Citation
Fox E, Razzouk BI, Widemann BC, Xiao S, O'Brien M, Goodspeed W, Reaman GH, Blaney SM, Murgo AJ, Balis FM, Adamson PC. Phase 1 trial and pharmacokinetic study of arsenic trioxide in children and adolescents with refractory or relapsed acute leukemia, including acute promyelocytic leukemia or lymphoma. Blood. 2008 Jan 15;111(2):566-73. doi: 10.1182/blood-2007-08-107839. Epub 2007 Oct 24.
Results Reference
result
Citation
Fox E, Adamson PC, Murgo A, et al.: Phase 1 trial and pharmacokinetic study of arsenic trioxide in children with refractory leukemia. [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-1582, 2002.
Results Reference
result
Learn more about this trial
Arsenic Trioxide in Treating Young Patients With Refractory Leukemia or Lymphoma
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