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

This study has been completed.

Sponsor:

Collaborator:

National Cancer Institute (NCI)

Information provided by:

Fred Hutchinson Cancer Research Center

ClinicalTrials.gov Identifier:

NCT00005940

First received: July 5, 2000

Last updated: August 20, 2010

Last verified: August 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

July 5, 2000

Last Updated Date

August 20, 2010

Start Date ^ICMJE

October 1999

Primary Completion Date

December 2003 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00005940 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Leukemia

Intervention ^ICMJE

Drug: busulfan
Drug: cyclophosphamide
Procedure: allogeneic bone marrow transplantation
Radiation: iodine I 131 monoclonal antibody BC8

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Not Provided

Completion Date

December 2003

Primary Completion Date

December 2003 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

16 Years to 55 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00005940

Other Study ID Numbers ^ICMJE

1470.00, FHCRC-1470.00, NCI-H00-0056, CDR0000067778

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Fred Hutchinson Cancer Research Center

Collaborators ^ICMJE

National Cancer Institute (NCI)

Investigators ^ICMJE

Study Chair:

John Pagel, MD, PhD

Fred Hutchinson Cancer Research Center

Information Provided By

Fred Hutchinson Cancer Research Center

Verification Date

August 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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