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Monoclonal Antibody Followed by Bone Marrow Transplantation in Treating Patients With Acute Myelogenous Leukemia in Remission or First Relapse

This study is ongoing, but not recruiting participants.

Sponsored by: Fred Hutchinson Cancer Research Center
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00002554
  Purpose

RATIONALE: Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Monoclonal antibody combined with a radioactive substance and given prior to bone marrow transplantation may kill more cancer cells.

PURPOSE: Phase II trial to study the effectiveness of radiolabeled monoclonal antibody given prior to bone marrow transplantation in treating patients with acute myelogenous leukemia.


Condition Intervention Phase
Leukemia
Drug: busulfan
Drug: cyclophosphamide
Drug: methotrexate
Procedure: allogeneic bone marrow transplantation
Procedure: radioimmunotherapy
Phase II

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

ChemIDplus related topics:   Cyclophosphamide    Methotrexate    Busulfan   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
Official Title:   RADIOLABELED BC8 (ANTI-CD45) ANTIBODY COMBINED WITH BUSULFAN AND CYCLOPHOSPHAMIDE AS TREATMENT FOR ACUTE MYELOGENOUS LEUKEMIA IN FIRST OR SECOND REMISSION OR UNTREATED FIRST RELAPSE FOLLOWED BY HLA-IDENTICAL RELATED MARROW TRANSPLANTATION

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

Estimated Enrollment:   30
Study Start Date:   November 1993

Detailed Description:

OBJECTIVES: I. Determine the overall and disease-free survival and toxicity associated with busulfan/cyclophosphamide (BU/CTX) plus 131I-labeled BC8 antibody (131I-BC8) followed by an HLA-identical related marrow transplant in patients with acute myelogenous leukemia in first or second remission or untreated first relapse. II. Study factors that may influence the biodistribution of 131I-BC8 in this patient population, including marrow cellularity, the level of antigen expression by leukemic cells (in relapsed patients), and the degree of antigen saturation by antibody. III. Determine the efficacy of BU/CTX in patients in first remission unable to receive radiolabeled antibody, e.g., patients who are HAMA-positive, those not tolerating antibody test infusion, those with unfavorable antibody biodistribution, or those for whom antibody is unavailable.

OUTLINE: Radioimmunotherapy plus 2-Drug Cytoreductive Chemotherapy followed by Bone Marrow Transplantation with, as indicated, CNS Therapy. Iodine-131-labeled Monoclonal Antibody BC8 (anti-CD45), 131I-BC8; plus Busulfan, BU, NSC-750; Cyclophosphamide, CTX, NSC-26271; followed by Allogeneic Bone Marrow, ABM; with, as indicated, Intrathecal Methotrexate, IT MTX, NSC-740.

PROJECTED ACCRUAL: It is anticipated that 30 patients in first remission, 30 patients in untreated first relapse, and 15 patients in second remission will be accrued over 3 years.

  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 or second remission or untreated first relapse Documented CD45 expression by leukemic cells required for patients in relapse Phenotyping not required for patients in remission; such patients may have leukemia previously documented to be CD45 negative Circulating blast count less than 10,000 (control with hydroxyurea or similar agent allowed) Genotypically or phenotypically HLA-matched related marrow donor required No donors mismatched for 1 or more HLA antigens No psychologic, physiologic, or medical contraindication to donation No high risk for anesthesia because of age or medical problems No HIV seropositive donors

PATIENT CHARACTERISTICS: Age: 16 to 55 Performance status: Not specified Life expectancy: Greater than 60 days Hematopoietic: Not applicable Hepatic: Bilirubin less than 1.5 mg/dl No risk of developing veno-occlusive disease of the liver (i.e., current evidence of hepatitis as manifested by SGOT greater than 1.5 x ULN) Renal: Creatinine less than 2.0 mg/dl Other: No HIV seropositivity No major infection

PRIOR CONCURRENT THERAPY: See Disease Characteristics No prior radiotherapy to maximally tolerated levels for any normal organ

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002554

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

Sponsors and Collaborators
Fred Hutchinson Cancer Research Center

Investigators
Study Chair:     Dana Christine Matthews, MD     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:   CDR0000063421, FHCRC-832.00, NCI-V94-0393
First Received:   November 1, 1999
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00002554
Health Authority:   United States: Federal Government

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

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

Additional relevant MeSH terms:
Antimetabolites
Antimetabolites, Antineoplastic
Neoplasms by Histologic Type
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Reproductive Control Agents
Folic Acid Antagonists
Abortifacient Agents, Nonsteroidal
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Therapeutic Uses
Abortifacient Agents
Myeloablative Agonists
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Dermatologic Agents
Alkylating Agents
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on September 16, 2008




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