Bone Marrow/bone Marrow Transplantation |
Bone Marrow Transplant; Bone Marrow Transplantation |
Clinical Trial: Monoclonal Antibody Therapy Plus Combination Chemotherapy and Bone Marrow Transplantation in Treating Patients With Acute Myelogenous Leukemia
This study is no longer recruiting patients.
Purpose
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.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| adult acute myeloid leukemia in remission | Drug: busulfan Drug: cyclophosphamide Drug: iodine I 131 monoclonal antibody BC8 Procedure: allogeneic bone marrow transplantation Procedure: antibody therapy Procedure: biological response modifier therapy Procedure: bone marrow ablation with stem cell support Procedure: bone marrow transplantation Procedure: chemotherapy Procedure: isotope therapy Procedure: monoclonal antibody therapy Procedure: radiation therapy Procedure: radioimmunotherapy | Phase II |
MedlinePlus related topics: Bone Marrow Diseases; Immune System and Disorders; Leukemia, Adult Acute; Leukemia, Adult Chronic; Leukemia, Childhood; Lymphatic Diseases
Study Type: Interventional
Study Design: Treatment
Official Title: Phase II Study of Iodine I 131 Monoclonal Antibody BC8 Plus Busulfan and Cyclophosphamide Followed by HLA Identical Related Bone Marrow Transplantation in Patients With Acute Myelogenous Leukemia in First Remission
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
Ages Eligible for Study: 16 Years - 55 Years, Genders Eligible for Study: Both
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
Location Information
John Pagel, MD, PhD, Study Chair, Fred Hutchinson Cancer Research Center
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Record last reviewed: April 2004
Last Updated: October 13, 2004
Record first received: July 5, 2000
ClinicalTrials.gov Identifier: NCT00005940
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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