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

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators: Fred Hutchinson Cancer Research Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00005940
  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 Intervention Phase
Leukemia
Drug: busulfan
Drug: cyclophosphamide
Drug: iodine I 131 monoclonal antibody BC8
Procedure: allogeneic bone marrow transplantation
Phase II

MedlinePlus related topics:   Bone Marrow Transplantation    Cancer    Leukemia, Adult Acute    Leukemia, Adult Chronic    Leukemia, Childhood   

ChemIDplus related topics:   Cyclophosphamide    Iodine    Cadexomer iodine    Sodium iodide I 131    Busulfan   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Open Label
Official Title:   Multicenter Phase II Study of Radiolabled BC8 (Anti-CD45) Antibody Combined With Busulfan and Cyclophosphamide as Treatment for Acute Myelogenous Leukemia in First Remission Followed by HLA-Identical Related Marrow Transplantation

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:   October 1999

Detailed Description:

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 to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00005940

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

Sponsors and Collaborators
Fred Hutchinson Cancer Research Center
National Cancer Institute (NCI)

Investigators
Study Chair:     John Pagel, MD, PhD     Fred Hutchinson Cancer Research Center    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000067778, FHCRC-1470.00, NCI-H00-0056
First Received:   July 5, 2000
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00005940
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
adult acute myeloid leukemia in remission  

Study placed in the following topic categories:
Antibodies, Monoclonal
Leukemia
Antibodies
Busulfan
Acute myelogenous leukemia
Iodine
Cyclophosphamide
Acute myeloid leukemia, adult
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Acute myelocytic leukemia

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Therapeutic Uses
Myeloablative Agonists
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Alkylating Agents

ClinicalTrials.gov processed this record on October 10, 2008




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