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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00003673
First received: November 1, 1999
Last updated: August 21, 2012
Last verified: August 2012
  Purpose

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: chemotherapy
Drug: gemtuzumab ozogamicin
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Study of the Safety of CMA-676 in Treatment of Elderly Patients With Acute Myeloid Leukemia (AML) in First Relapse

Resource links provided by NLM:


Further study details as provided by Pfizer:

Estimated Enrollment: 55
Study Start Date: March 1998
Study Completion Date: March 1999
Primary Completion Date: March 1999 (Final data collection date for primary outcome measure)
Detailed 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.

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003673

Locations
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
Sponsors and Collaborators
Pfizer
Investigators
Study Chair: Mark Stanley Berger, MD Wyeth is now a wholly owned subsidiary of Pfizer
  More Information

Additional Information:
Publications:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00003673     History of Changes
Other Study ID Numbers: W-AR-0903B1-203-US, CDR0000066771, NCI-V98-1497
Study First Received: November 1, 1999
Last Updated: August 21, 2012
Health Authority: United States: Federal Government

Keywords provided by Pfizer:
recurrent adult acute myeloid leukemia

Additional relevant MeSH terms:
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Leukemia
Neoplasms by Histologic Type
Neoplasms
Gemtuzumab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 19, 2014