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Monoclonal Antibody Therapy Plus Combination Chemotherapy and Bone Marrow Transplantation in Treating Patients With Acute Myelogenous Leukemia



Monoclonal Antibody Therapy Plus Combination Chemotherapy and Bone Marrow Transplantation in Treating Patients With Acute Myelogenous Leukemia

For Condition: adult acute myeloid leukemia in remission
Status: No longer recruiting
Sponsor(s): Fred Hutchinson Cancer Research Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Bone marrow transplantation may be able to replace immune cells that were destroyed by chemotherapy used to kill cancer cells. PURPOSE: Phase II trial to study the effectiveness of monoclonal antibody therapy plus combination chemotherapy and bone marrow transplantation in treating patients who have acute myelogenous leukemia.
Details: OBJECTIVES: - Determine the disease-free and overall survival of patients with acute myelogenous leukemia in first remission treated with busulfan and cyclophosphamide plus iodine I 131 monoclonal antibody BC8 followed by HLA identical related bone marrow transplantation. - Determine the toxicity of this regimen in these patients. OUTLINE: This is a multicenter study. Patients receive a test dose of iodine I 131 monoclonal antibody BC8 (I131 MOAB BC8) IV, then about 2 weeks later, on day -13, a therapeutic dose of I131 MOAB BC8 IV is administered. Patients then receive oral busulfan every 6 hours on days -7 to -4 (16 doses) and cyclophosphamide IV on days -3 and -2. Donor bone marrow is infused on day 0. Patients are followed at 6, 9, and 12 months, then every 6 months for 1 year, then annually thereafter. PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
Eligibility:
Study Type:  Interventional, Treatment
Minimum Age/Maximum Age: 16 Years/55 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Acute myelogenous leukemia in first remission - No prior or concurrent CNS involvement by leukemia - Genotypically or phenotypically HLA matched family member available as donor PATIENT CHARACTERISTICS: Age - 16 to 55 Performance status - Not specified Life expectancy - More than 60 days Hematopoietic - Not specified Hepatic - Bilirubin less than 1.5 mg/dL - AST no greater than 1.5 times upper limit of normal - No current hepatitis - No high risk for developing veno-occlusive disease of the liver Renal - Creatinine less than 2.0 mg/dL Other - HIV negative - No major infection - No perceived inability to tolerate study procedures, particularly treatment in radiation isolation - No circulating antibody to mouse immunoglobulin - Not pregnant or nursing - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - Not specified Endocrine therapy - Not specified Radiotherapy - No prior radiotherapy to maximum tolerated levels to any normal organ Surgery - Not specified
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
JohnPagel,  Study Chair,  Fred Hutchinson Cancer Research Center

Fred Hutchinson Cancer Research Center
Seattle,  Washington,  98109-1024
United States
 


Additional Information:
Study ID Numbers:  CDR0000067778;  FHCRC-1470.00,NCI-H00-0056
Study Start Date: 
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005940

Other Adult Acute Myeloid Leukemia In Remission Studies:
1. Chemotherapy Plus Monoclonal Antibody in Treating Patients With Acute Promyelocytic Leukemia

2. Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation and Low-Dose Interleukin-2 in Treating Patients With Acute Myelogenous Leukemia

3. Total-Body Irradiation Plus Stem Cell Transplantation And White Blood Cell Infusion in Treating Older Patients With Acute Myeloid Leukemia

4. Donor Bone Marrow Transplantation in Treating Patients With Hematologic Cancer

5. Monoclonal Antibody Therapy Plus Combination Chemotherapy and Bone Marrow Transplantation in Treating Patients With Acute Myelogenous Leukemia

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