Gemtuzumab Ozogamicin and High-Dose Cytarabine in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia
- Registration Number
- NCT00006265
- Lead Sponsor
- Alliance for Clinical Trials in Oncology
- Brief Summary
RATIONALE: Monoclonal antibodies, such as gemtuzumab ozogamicin, can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy, such as cytarabine, use different ways to stop cancer cells from dividing so they stop growing or die. Combining gemtuzumab ozogamicin with cytarabine may kill more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of combining gemtuzumab ozogamicin with high-dose cytarabine in treating patients who have relapsed or refractory acute myeloid leukemia.
- Detailed Description
OBJECTIVES:
* Determine the response rate in patients with relapsed or refractory acute myeloid leukemia treated with gemtuzumab ozogamicin (CMA-676) and high-dose cytarabine.
* Determine the safety and toxicity of this regimen in these patients.
OUTLINE: This is a dose-escalation study of gemtuzumab ozogamicin (CMA-676) (phase I closed to accrual effective 08/25/2003). Patients are stratified according to disease status (refractory vs relapsed).
* Phase I (closed to accrual effective 08/25/2003): Patients are enrolled in one of four cohorts.
* Cohort I (closed to accrual as of 10/1/02): Patients receive CMA-676 at the first dose level IV over 2 hours on days 1 and 8.
* Cohort IA (open to accrual as of 10/15/02): Patients receive high-dose cytarabine (HD-ARA-C) IV over 3 hours on days 1-5 and CMA-676 IV over 2 hours on day 7.
* Cohort II: Patients receive HD-ARA-C as in cohort IA and CMA-676 at the first dose level IV over 2 hours on days 7 and 14.
* Cohort IV: Patients receive CMA-676 at the second dose level and HD-ARA-C as in cohort II.
Dose escalation stops if at least 3 of 9 patients experience dose-limiting toxicity.
* Phase II: Patients receive HD-ARA-C IV over 3 hours on days 1-5 and CMA-676 IV over 2 hours on day 7 (one course).
Patients are followed at 1 month, monthly for 6 months, every 3 months for 2 years, and then annually for 10 years.
PROJECTED ACCRUAL: A total of 36 patients will be accrued for phase I of the study and a total of 37 patients will be accrued for phase II of the study within 2 years. (Phase I closed to accrual effective 08/25/2003).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort IA ara-C Gemtuzumab + ara C Cohort IV ara-C Gemtuzumab + ara-C Cohort IV gemtuzumab ozogamicin Gemtuzumab + ara-C Cohort II gemtuzumab ozogamicin Gemtuzumab + ara-C Cohort IA gemtuzumab ozogamicin Gemtuzumab + ara C Cohort I gemtuzumab ozogamicin Immunotherapy with gemtuzumab Cohort II ara-C Gemtuzumab + ara-C
- Primary Outcome Measures
Name Time Method Complete remission rate 8 or 14 days after tx initiation & 30 d post tx
- Secondary Outcome Measures
Name Time Method Toxicity D 14, then 30, 60 , & 90 d post Tx, q 3 mon for 1 yr, then at relapse or death
Trial Locations
- Locations (78)
Northeast Alabama Regional Medical Center
🇺🇸Anniston, Alabama, United States
Veterans Affairs Medical Center - Birmingham
🇺🇸Birmingham, Alabama, United States
Rebecca and John Moores UCSD Cancer Center
🇺🇸La Jolla, California, United States
Veterans Affairs Medical Center - San Diego
🇺🇸San Diego, California, United States
UCSF Comprehensive Cancer Center
🇺🇸San Francisco, California, United States
Veterans Affairs Medical Center - San Francisco
🇺🇸San Francisco, California, United States
CCOP - Christiana Care Health Services
🇺🇸Newark, Delaware, United States
Lombardi Cancer Center at Georgetown University Medical Center
🇺🇸Washington, District of Columbia, United States
Walter Reed Army Medical Center
🇺🇸Washington, District of Columbia, United States
Veterans Affairs Medical Center - Washington, DC
🇺🇸Washington, District of Columbia, United States
Scroll for more (68 remaining)Northeast Alabama Regional Medical Center🇺🇸Anniston, Alabama, United States