Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Wyeth |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00003673 |
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.
Condition | Intervention | Phase |
---|---|---|
Leukemia |
Drug: gemtuzumab ozogamicin Procedure: chemotherapy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Study of the Safety of CMA-676 in Treatment of Elderly Patients With Acute Myeloid Leukemia (AML) in First Relapse |
Estimated Enrollment: | 55 |
Study Start Date: | March 1998 |
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.
Ages Eligible for Study: | 60 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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
United States, Arizona | |
Arizona Cancer Center | |
Tucson, Arizona, United States, 85724 | |
United States, California | |
Jonsson Comprehensive Cancer Center, UCLA | |
Los Angeles, California, United States, 90095-1781 | |
United States, Illinois | |
Robert H. Lurie Comprehensive Cancer Center, Northwestern University | |
Chicago, Illinois, United States, 60611 | |
University of Chicago Cancer Research Center | |
Chicago, Illinois, United States, 60637 | |
United States, Massachusetts | |
New England Medical Center Hospital | |
Boston, Massachusetts, United States, 02111 | |
United States, Michigan | |
Barbara Ann Karmanos Cancer Institute | |
Detroit, Michigan, United States, 48201 | |
United States, New York | |
Long Island Jewish Medical Center | |
New Hyde Park, New York, United States, 11040 | |
New York Presbyterian Hospital - Cornell Campus | |
New York, New York, United States, 10021 | |
State University of New York Health Sciences Center - Stony Brook | |
Stony Brook, New York, United States, 11790-9832 | |
United States, Pennsylvania | |
University of Pennsylvania Cancer Center | |
Philadelphia, Pennsylvania, United States, 19104 |
Study Chair: | Mark Stanley Berger, MD | Wyeth |
Study ID Numbers: | CDR0000066771, W-AR-0903B1-203-US, NCI-V98-1497 |
Study First Received: | November 1, 1999 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00003673 |
Health Authority: | United States: Federal Government |
recurrent adult acute myeloid leukemia |
Leukemia Acute myelogenous leukemia Acute myeloid leukemia, adult Leukemia, Myeloid |
Gemtuzumab Leukemia, Myeloid, Acute Acute myelocytic leukemia Recurrence |
Neoplasms Neoplasms by Histologic Type Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |