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Combination Chemotherapy Followed by Bone Marrow Transplantation in Treating Patients With Advanced Hematologic Cancer

Primary Purpose

Graft Versus Host Disease, Leukemia, Myelodysplastic Syndromes

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
busulfan
melphalan
methotrexate
tacrolimus
allogeneic bone marrow transplantation
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Graft Versus Host Disease focused on measuring recurrent childhood acute lymphoblastic leukemia, recurrent childhood acute myeloid leukemia, recurrent adult acute myeloid leukemia, recurrent adult acute lymphoblastic leukemia, relapsing chronic myelogenous leukemia, refractory chronic lymphocytic leukemia, chronic phase chronic myelogenous leukemia, accelerated phase chronic myelogenous leukemia, blastic phase chronic myelogenous leukemia, adult acute myeloid leukemia in remission, adult acute lymphoblastic leukemia in remission, childhood acute myeloid leukemia in remission, childhood acute lymphoblastic leukemia in remission, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, chronic myelomonocytic leukemia, acute undifferentiated leukemia, secondary acute myeloid leukemia, de novo myelodysplastic syndromes, previously treated myelodysplastic syndromes, secondary myelodysplastic syndromes, graft versus host disease, refractory cytopenia with multilineage dysplasia, juvenile myelomonocytic leukemia, childhood chronic myelogenous leukemia, atypical chronic myeloid leukemia, BCR-ABL1 negative, myelodysplastic/myeloproliferative neoplasm, unclassifiable, adult acute myeloid leukemia with t(8;21)(q22;q22), adult acute myeloid leukemia with t(16;16)(p13;q22), adult acute myeloid leukemia with inv(16)(p13;q22), adult acute myeloid leukemia with 11q23 (MLL) abnormalities, adult acute myeloid leukemia with t(15;17)(q22;q12)

Eligibility Criteria

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

DISEASE CHARACTERISTICS: Diagnosis of one of the following: Infant leukemia Acute lymphoblastic leukemia in 3rd or greater remission or relapse Undifferentiated or biphenotypic leukemia in 2nd or greater remission or relapse Juvenile chronic myelogenous leukemia (CML) Acute myelogenous leukemia (AML) in 3rd or greater remission or relapse Primary advanced myelodysplastic syndrome (MDS) excluding refractory anemia (RA) and RA with ringed sideroblasts Therapy-related MDS of any stage or AML CML in 2nd or greater chronic phase, accelerated, or blastic phase Acute leukemia, CML, or MDS but unable to tolerate total body irradiation (TBI) due to potential neurotoxicity (prior TBI, prior local radiotherapy,or under 2 years of age) No active CNS disease Related or unrelated bone marrow donor matched at HLA-A, B, and DR beta 1 PATIENT CHARACTERISTICS: Age: Under 60 (over 60 considered on case-by-case basis) Performance status: Karnofsky 70-100% Lansky 70-100% Life expectancy: Not specified Hematopoietic: Not specified Hepatic: AST and ALT less than 2 times upper limit of normal Bilirubin less than 1.5 mg/dL unless liver is involved with disease Renal: Creatinine normal Creatinine clearance greater than 60 mL/min Cardiovascular: Asymptomatic with no prior risk factors OR LVEF greater than 50% if symptomatic Pulmonary: Asymptomatic with no prior risk factors OR Diffusion capacity greater than 50% predicted (corrected for hemoglobin) if symptomatic Other: No active uncontrolled viral, bacterial, or fungal infection Not pregnant or nursing Negative pregnancy test HIV negative PRIOR CONCURRENT THERAPY: Biologic therapy: More than 6 months since prior allogeneic or autologous stem cell transplantation Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics Surgery: Not specified

Sites / Locations

  • Memorial Sloan-Kettering Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
April 10, 2001
Last Updated
March 6, 2013
Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00014469
Brief Title
Combination Chemotherapy Followed by Bone Marrow Transplantation in Treating Patients With Advanced Hematologic Cancer
Official Title
A Phase II Trial of IV Busulfan (Busulfex) and Melphalan as a Preparatory Regimen Prior to Allogeneic Bone Marrow Transplantation for the Treatment of Advanced and High Risk Hematologic Malignancies
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
December 2000 (undefined)
Primary Completion Date
May 2007 (Actual)
Study Completion Date
May 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of busulfan and melphalan followed by donor bone marrow transplantation in treating patients who have advanced hematologic cancer.
Detailed Description
OBJECTIVES: Determine the antileukemic potential of busulfan and melphalan prior to allogeneic bone marrow transplantation in patients with advanced or high-risk hematologic malignancy. Determine the incidence of transplantation-related morbidity and mortality in patients treated with this regimen. Determine the incidence of acute and chronic graft-versus-host disease in patients treated with this regimen. OUTLINE: Patients receive cytoreductive chemotherapy comprising busulfan IV over 2 hours every 6 hours for a total of 16 doses on days -8 to -5 and melphalan IV over 30 minutes on days -4 to -2. Patients undergo T-cell replete allogeneic bone marrow transplantation on day 0. For graft-versus-host disease prophylaxis, patients receive tacrolimus IV continuously or every 12 hours beginning on day -1 and continuing for 50 days to 6 months followed by a taper. Once oral medications are tolerated, patients switch to oral tacrolimus every 12 hours. Patients also receive methotrexate IV on days 1, 3, 6, and 11. Patients are followed weekly through day 100, every 6 weeks for 3 months, every 3 months for 1 year, and then every 3-6 months for 6 months. PROJECTED ACCRUAL: A maximum of 30 patients will be accrued for this study within 3 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Graft Versus Host Disease, Leukemia, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Neoplasms
Keywords
recurrent childhood acute lymphoblastic leukemia, recurrent childhood acute myeloid leukemia, recurrent adult acute myeloid leukemia, recurrent adult acute lymphoblastic leukemia, relapsing chronic myelogenous leukemia, refractory chronic lymphocytic leukemia, chronic phase chronic myelogenous leukemia, accelerated phase chronic myelogenous leukemia, blastic phase chronic myelogenous leukemia, adult acute myeloid leukemia in remission, adult acute lymphoblastic leukemia in remission, childhood acute myeloid leukemia in remission, childhood acute lymphoblastic leukemia in remission, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, chronic myelomonocytic leukemia, acute undifferentiated leukemia, secondary acute myeloid leukemia, de novo myelodysplastic syndromes, previously treated myelodysplastic syndromes, secondary myelodysplastic syndromes, graft versus host disease, refractory cytopenia with multilineage dysplasia, juvenile myelomonocytic leukemia, childhood chronic myelogenous leukemia, atypical chronic myeloid leukemia, BCR-ABL1 negative, myelodysplastic/myeloproliferative neoplasm, unclassifiable, adult acute myeloid leukemia with t(8;21)(q22;q22), adult acute myeloid leukemia with t(16;16)(p13;q22), adult acute myeloid leukemia with inv(16)(p13;q22), adult acute myeloid leukemia with 11q23 (MLL) abnormalities, adult acute myeloid leukemia with t(15;17)(q22;q12)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
busulfan
Intervention Type
Drug
Intervention Name(s)
melphalan
Intervention Type
Drug
Intervention Name(s)
methotrexate
Intervention Type
Drug
Intervention Name(s)
tacrolimus
Intervention Type
Procedure
Intervention Name(s)
allogeneic bone marrow transplantation

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Diagnosis of one of the following: Infant leukemia Acute lymphoblastic leukemia in 3rd or greater remission or relapse Undifferentiated or biphenotypic leukemia in 2nd or greater remission or relapse Juvenile chronic myelogenous leukemia (CML) Acute myelogenous leukemia (AML) in 3rd or greater remission or relapse Primary advanced myelodysplastic syndrome (MDS) excluding refractory anemia (RA) and RA with ringed sideroblasts Therapy-related MDS of any stage or AML CML in 2nd or greater chronic phase, accelerated, or blastic phase Acute leukemia, CML, or MDS but unable to tolerate total body irradiation (TBI) due to potential neurotoxicity (prior TBI, prior local radiotherapy,or under 2 years of age) No active CNS disease Related or unrelated bone marrow donor matched at HLA-A, B, and DR beta 1 PATIENT CHARACTERISTICS: Age: Under 60 (over 60 considered on case-by-case basis) Performance status: Karnofsky 70-100% Lansky 70-100% Life expectancy: Not specified Hematopoietic: Not specified Hepatic: AST and ALT less than 2 times upper limit of normal Bilirubin less than 1.5 mg/dL unless liver is involved with disease Renal: Creatinine normal Creatinine clearance greater than 60 mL/min Cardiovascular: Asymptomatic with no prior risk factors OR LVEF greater than 50% if symptomatic Pulmonary: Asymptomatic with no prior risk factors OR Diffusion capacity greater than 50% predicted (corrected for hemoglobin) if symptomatic Other: No active uncontrolled viral, bacterial, or fungal infection Not pregnant or nursing Negative pregnancy test HIV negative PRIOR CONCURRENT THERAPY: Biologic therapy: More than 6 months since prior allogeneic or autologous stem cell transplantation Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics Surgery: Not specified
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Trudy N. Small, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States

12. IPD Sharing Statement

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Combination Chemotherapy Followed by Bone Marrow Transplantation in Treating Patients With Advanced Hematologic Cancer

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