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| 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 Radiation: radioimmunotherapy |
Phase II |
| 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 |
| Estimated Enrollment: | 30 |
| Study Start Date: | November 1993 |
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 |
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| United States, Washington | |
| Fred Hutchinson Cancer Research Center | |
| Seattle, Washington, United States, 98109 | |
| Study Chair: | Dana Christine Matthews, MD | Fred Hutchinson Cancer Research Center |
More Information
| Study ID Numbers: | CDR0000063421, FHCRC-832.00, NCI-V94-0393 |
| Study First Received: | November 1, 1999 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00002554 History of Changes |
| Health Authority: | United States: Federal Government |
|
recurrent adult acute myeloid leukemia adult acute myeloid leukemia in remission |
|
Antimetabolites Immunologic Factors Leukemia, Myeloid Cyclophosphamide Folic Acid Antagonists Leukemia, Myeloid, Acute Immunosuppressive Agents Recurrence Folic Acid Antibodies, Monoclonal |
Leukemia Acute Myelocytic Leukemia Antibodies Acute Myeloid Leukemia, Adult Busulfan Methotrexate Antineoplastic Agents, Alkylating Antirheumatic Agents Alkylating Agents Immunoglobulins |
|
Antimetabolites Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Cyclophosphamide Reproductive Control Agents Leukemia, Myeloid, Acute Leukemia Therapeutic Uses Abortifacient Agents Methotrexate Alkylating Agents |
Dermatologic Agents Nucleic Acid Synthesis Inhibitors Neoplasms by Histologic Type Enzyme Inhibitors Leukemia, Myeloid Folic Acid Antagonists Abortifacient Agents, Nonsteroidal Immunosuppressive Agents Pharmacologic Actions Neoplasms Busulfan Myeloablative Agonists Antineoplastic Agents, Alkylating Antirheumatic Agents |
