Acute Myeloid Leukemia Clinical Trial

CMA-676 in Treating Older Patients With Acute Myeloid Leukemia in First Relapse

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of CMA-676 in treating older patients who have acute myeloid leukemia that has recurred for the first time following at least 3 months of complete remission.

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Full Description

OBJECTIVES: I. Assess the efficacy of CMA-676 in elderly patients with acute myeloid leukemia in first relapse in terms of the number of patients attaining a complete remission. II. Assess the safety of CMA-676 in this patient population.

OUTLINE: This is an open label, single arm, multicenter study. Patients receive 1 course of CMA-676 IV over 2 hours on day 1 followed by a 6 hour observation period. Patients may receive 1 additional course of therapy 15 to 28 days later. There is a 28 day follow-up period after the last dose of study medication. Patients are followed for an additional 6 months, then every 3 months for 18 months, and then every 6 months until relapse and/or death.

PROJECTED ACCRUAL: A total of 23-55 patients will be accrued for this study within 12 months. Enrollment will then be extended for up to an additional 55 patients.

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Eligibility Criteria

DISEASE CHARACTERISTICS: CD33 positive acute myeloid leukemia in first relapse At least 3 months of complete remission No history of a secondary leukemia evolving from a known prior myelodysplastic syndrome or resulting from exposure to chemotherapy or toxins No active CNS leukemia

PATIENT CHARACTERISTICS: Age: 60 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: WBC less than 30,000/mm3 at time of CMA-676 administration Hepatic: Bilirubin no greater than 2.0 mg/dL Renal: Creatinine no greater than 3.0 mg/dL Cardiovascular: No uncontrolled cardiac disease Pulmonary: No uncontrolled pulmonary disease Other: No other active malignancy No uncontrolled, life-threatening infections Able to obtain bone marrow aspirate HIV negative

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior bone marrow and peripheral blood stem cells transplantation No prior anti-CD33 antibody therapy Chemotherapy: Prior cytotoxic chemotherapy for AML allowed No prior chemotherapy for AML in first relapse except hydroxyurea At least 24 hours since prior hydroxyurea Recovered from prior antineoplastic therapy (except alopecia) No concurrent cytotoxic chemotherapy Endocrine therapy: No concurrent immunosuppressive therapy Radiotherapy: Not specified Surgery: Not specified Other: At least 4 weeks since prior investigational agents No other concurrent antileukemic therapy

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 2

Estimated Enrollment:

55

Study ID:

NCT00003673

Recruitment Status:

Completed

Sponsor:

Pfizer

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There are 10 Locations for this study

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Arizona Cancer Center
Tucson Arizona, 85724, United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles California, 90095, United States
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago Illinois, 60611, United States
University of Chicago Cancer Research Center
Chicago Illinois, 60637, United States
New England Medical Center Hospital
Boston Massachusetts, 02111, United States
Barbara Ann Karmanos Cancer Institute
Detroit Michigan, 48201, United States
Long Island Jewish Medical Center
New Hyde Park New York, 11040, United States
New York Presbyterian Hospital - Cornell Campus
New York New York, 10021, United States
State University of New York Health Sciences Center - Stony Brook
Stony Brook New York, 11790, United States
University of Pennsylvania Cancer Center
Philadelphia Pennsylvania, 19104, United States

How clear is this clinincal trial information?

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 2

Estimated Enrollment:

55

Study ID:

NCT00003673

Recruitment Status:

Completed

Sponsor:


Pfizer

How clear is this clinincal trial information?

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