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


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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.

Sponsors and Collaborators: Fred Hutchinson Cancer Research Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)

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

Further Study Details: 

OBJECTIVES:

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


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

Study chairs or principal investigators

John Pagel, MD, PhD,  Study Chair,  Fred Hutchinson Cancer Research Center   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000067778; FHCRC-1470.00; NCI-H00-0056
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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October 10, 2008



Page Updated: October 1, 2005
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