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

Sponsor:	Fred Hutchinson Cancer Research Center
Collaborator:	National Cancer Institute (NCI)
Information provided by:	Fred Hutchinson Cancer Research Center
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 Procedure: allogeneic bone marrow transplantation Radiation: iodine I 131 monoclonal antibody BC8	Phase II

Study Type:	Interventional
Study Design:	Masking: Open Label Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Acute Myeloid Leukemia Bone Marrow Transplantation Cancer Leukemia

Drug Information available for: Cyclophosphamide Busulfan Immunoglobulins Iodine Globulin, Immune

U.S. FDA Resources

Further study details as provided by Fred Hutchinson Cancer Research Center:

Study Start Date:	October 1999
Study Completion Date:	December 2003
Primary Completion Date:	December 2003 (Final data collection date for primary outcome measure)

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

Additional Information:

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

No publications provided

ClinicalTrials.gov Identifier:	NCT00005940 History of Changes
Other Study ID Numbers:	1470.00, FHCRC-1470.00, NCI-H00-0056, CDR0000067778
Study First Received:	July 5, 2000
Last Updated:	August 20, 2010
Health Authority:	United States: Federal Government; United States: Food and Drug Administration; United States: Institutional Review Board

Keywords provided by Fred Hutchinson Cancer Research Center:

adult acute myeloid leukemia in remission

Additional relevant MeSH terms:

Leukemia
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Neoplasms by Histologic Type
Neoplasms
Antibodies
Immunoglobulins
Antibodies, Monoclonal
Busulfan
Cyclophosphamide
Immunologic Factors

Physiological Effects of Drugs
Pharmacologic Actions
Immunosuppressive Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Myeloablative Agonists
Antirheumatic Agents

ClinicalTrials.gov processed this record on February 12, 2012