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)
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
🇺🇸Syracuse, New York, United States
Veterans Affairs Medical Center - Dallas
🇺🇸Dallas, Texas, United States
CCOP - Mount Sinai Medical Center
🇺🇸Miami Beach, Florida, United States
Saint Anthony Medical Center
🇺🇸Rockford, Illinois, United States
Louis A. Weiss Memorial Hospital
🇺🇸Chicago, Illinois, United States
Rebecca and John Moores UCSD Cancer Center
🇺🇸La Jolla, California, United States
Veterans Affairs Medical Center - Buffalo
🇺🇸Buffalo, New York, United States
CCOP - Illinois Oncology Research Association
🇺🇸Peoria, Illinois, United States
Cooper University Hospital
🇺🇸Camden, New Jersey, United States
Memorial Sloan-Kettering Cancer Center
🇺🇸New York, New York, United States
Mount Sinai Medical Center, NY
🇺🇸New York, New York, United States
Palm Beach Cancer Institute
🇺🇸West Palm Beach, Florida, United States
Fort Wayne Medical Oncology and Hematology, Incorporated
🇺🇸Fort Wayne, Indiana, United States
Marlene and Stewart Greenebaum Cancer Center, University of Maryland
🇺🇸Baltimore, Maryland, United States
Barnes-Jewish Hospital
🇺🇸St. Louis, Missouri, United States
University of Chicago Cancer Research Center
🇺🇸Chicago, Illinois, United States
University Hospital at State University of New York - Upstate Medical University
🇺🇸Syracuse, New York, United States
West Suburban Center for Cancer Care
🇺🇸River Forest, Illinois, United States
CCOP - North Shore University Hospital
🇺🇸Manhasset, New York, United States
Veterans Affairs Medical Center - Syracuse
🇺🇸Syracuse, New York, United States
Veterans Affairs Medical Center - Columbia (Truman Memorial)
🇺🇸Columbia, Missouri, United States
New Hampshire Oncology-Hematology, PA - Hooksett
🇺🇸Hooksett, New Hampshire, United States
FirstHealth Moore Regional Hospital
🇺🇸Pinehurst, North Carolina, United States
New Hanover Regional Medical Center
🇺🇸Wilmington, North Carolina, United States
Elmhurst Hospital Center
🇺🇸Elmhurst, New York, United States
Lenoir Memorial Hospital Cancer Center
🇺🇸Kinston, North Carolina, United States
Arthur G. James Cancer Hospital - Ohio State University
🇺🇸Columbus, Ohio, United States
University of Tennessee Cancer Institute
🇺🇸Memphis, Tennessee, United States
Martha Jefferson Hospital
🇺🇸Charlottesville, Virginia, United States
Oncology and Hematology Associates of Southwest Virginia, Inc.
🇺🇸Roanoke, Virginia, United States
Green Mountain Oncology Group
🇺🇸Bennington, Vermont, United States
Veterans Affairs Medical Center - White River Junction
🇺🇸White River Junction, Vermont, United States
University of Puerto Rico School of Medicine Medical Sciences Campus
🇵🇷San Juan, Puerto Rico
St. Mary's Medical Center
🇺🇸Huntington, West Virginia, United States
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
CCOP - Southern Nevada Cancer Research Foundation
🇺🇸Las Vegas, Nevada, United States
Veterans Affairs Medical Center - Las Vegas
🇺🇸Las Vegas, Nevada, United States
Queens Cancer Center of Queens Hospital
🇺🇸Jamaica, New York, United States
Northeast Alabama Regional Medical Center
🇺🇸Anniston, Alabama, United States
Broward General Medical Center
🇺🇸Fort Lauderdale, Florida, United States
Memorial Regional Hospital Comprehensive Cancer Center
🇺🇸Hollywood, Florida, United States
Veterans Affairs Medical Center - Chicago (Westside Hospital)
🇺🇸Chicago, Illinois, United States
Hematology Oncology Associates of the Quad Cities
🇺🇸Bettendorf, Iowa, United States
Holden Comprehensive Cancer Center at University of Iowa
🇺🇸Iowa City, Iowa, United States
Veterans Affairs Medical Center - Asheville
🇺🇸Asheville, North Carolina, United States
Ellis Fischel Cancer Center at University of Missouri - Columbia
🇺🇸Columbia, Missouri, United States
NorthEast Oncology Associates
🇺🇸Concord, North Carolina, United States
Veterans Affairs Medical Center - Memphis
🇺🇸Memphis, Tennessee, United States
Lifespan: The Miriam Hospital
🇺🇸Providence, Rhode Island, United States
Vermont Cancer Center at University of Vermont
🇺🇸Burlington, Vermont, United States
Virginia Oncology Associates - Norfolk
🇺🇸Norfolk, Virginia, United States
Veterans Affairs Medical Center - Birmingham
🇺🇸Birmingham, Alabama, 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
Veterans Affairs Medical Center - Minneapolis
🇺🇸Minneapolis, Minnesota, United States
University of Minnesota Cancer Center
🇺🇸Minneapolis, Minnesota, United States
Oklahoma University Medical Center at University of Oklahoma Health Sciences Center
🇺🇸Oklahoma City, Oklahoma, United States
Veterans Affairs Medical Center - Durham
🇺🇸Durham, North Carolina, United States
Duke Comprehensive Cancer Center
🇺🇸Durham, North Carolina, United States
UNMC Eppley Cancer Center at the University of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
North Shore University Hospital
🇺🇸Manhasset, New York, United States
New York Weill Cornell Cancer Center at Cornell University
🇺🇸New York, New York, United States
Cape Fear Valley Health System
🇺🇸Fayetteville, North Carolina, United States
MBCCOP - Massey Cancer Center
🇺🇸Richmond, Virginia, United States
Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph
🇺🇸Saint Joseph, Michigan, 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
Norris Cotton Cancer Center at Dartmouth Medical School
🇺🇸Lebanon, New Hampshire, United States
University of Massachusetts Memorial Medical Center - University Campus
🇺🇸Worcester, Massachusetts, 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
Florida Hospital Cancer Institute
🇺🇸Orlando, Florida, United States
Baptist Hospital East - Louisville
🇺🇸Louisville, Kentucky, United States
CCOP - Kansas City
🇺🇸Kansas City, Missouri, United States
Comprehensive Cancer Center at Wake Forest University
🇺🇸Winston-Salem, North Carolina, United States
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
CCOP - Southeast Cancer Control Consortium
🇺🇸Winston-Salem, North Carolina, United States