A Dose Escalation And Phase II Study Of Gemtuzumab Ozogamicin (CMA-676; Mylotarg) With High-Dose Cytarabine For Patients With Refractory Or Relapsed Acute Myeloid Leukemia (AML)
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).
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Complete remission rate
8 or 14 days after tx initiation & 30 d post tx
No
Richard M. Stone, MD
Study Chair
Dana-Farber Cancer Institute
United States: Food and Drug Administration
CDR0000068208
NCT00006265
March 2001
May 2005
Name | Location |
---|---|
Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
Walter Reed Army Medical Center | Washington, District of Columbia 20307-5000 |
University of Chicago Cancer Research Center | Chicago, Illinois 60637 |
University of Minnesota Cancer Center | Minneapolis, Minnesota 55455 |
Duke Comprehensive Cancer Center | Durham, North Carolina 27710 |
Arthur G. James Cancer Hospital - Ohio State University | Columbus, Ohio 43210 |
CCOP - Kansas City | Kansas City, Missouri 64131 |
CCOP - Southern Nevada Cancer Research Foundation | Las Vegas, Nevada 89106 |
CCOP - Christiana Care Health Services | Wilmington, Delaware 19899 |
CCOP - Mount Sinai Medical Center | Miami Beach, Florida 33140 |
Barnes-Jewish Hospital | Saint Louis, Missouri 63110 |
CCOP - North Shore University Hospital | Manhasset, New York 11030 |
CCOP - Southeast Cancer Control Consortium | Winston-Salem, North Carolina 27104-4241 |
MBCCOP - Massey Cancer Center | Richmond, Virginia 23298-0037 |
Mount Sinai Medical Center, NY | New York, New York 10029 |
CCOP - Illinois Oncology Research Association | Peoria, Illinois 61602 |
Comprehensive Cancer Center at Wake Forest University | Winston-Salem, North Carolina 27157-1082 |
Veterans Affairs Medical Center - Birmingham | Birmingham, Alabama 35233 |
Green Mountain Oncology Group | Rutland, Vermont 05701 |
Veterans Affairs Medical Center - White River Junction | White River Junction, Vermont 05009 |
Martha Jefferson Hospital | Charlottesville, Virginia 22901 |
Holden Comprehensive Cancer Center at University of Iowa | Iowa City, Iowa 52242-1002 |
Ellis Fischel Cancer Center at University of Missouri - Columbia | Columbia, Missouri 65203 |
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | Chapel Hill, North Carolina 27599-7570 |
North Shore University Hospital | Manhasset, New York 11030 |
Veterans Affairs Medical Center - Chicago (Westside Hospital) | Chicago, Illinois 60612 |
Veterans Affairs Medical Center - San Francisco | San Francisco, California 94121 |
Baptist Hospital East - Louisville | Louisville, Kentucky 40207 |
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C. | Syracuse, New York 13217 |
Veterans Affairs Medical Center - Memphis | Memphis, Tennessee 38104 |
Oncology and Hematology Associates of Southwest Virginia, Inc. | Roanoke, Virginia 24014 |
Veterans Affairs Medical Center - Minneapolis | Minneapolis, Minnesota 55417 |
Veterans Affairs Medical Center - Columbia (Truman Memorial) | Columbia, Missouri 65201 |
Veterans Affairs Medical Center - Buffalo | Buffalo, New York 14215 |
Veterans Affairs Medical Center - Syracuse | Syracuse, New York 13210 |
Veterans Affairs Medical Center - Durham | Durham, North Carolina 27705 |
Rebecca and John Moores UCSD Cancer Center | La Jolla, California 92093-0658 |
Broward General Medical Center | Fort Lauderdale, Florida 33316 |
Florida Hospital Cancer Institute | Orlando, Florida 32804 |
Marlene and Stewart Greenebaum Cancer Center, University of Maryland | Baltimore, Maryland 21201-1595 |
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | Boston, Massachusetts 02115 |
University of Massachusetts Memorial Medical Center - University Campus | Worcester, Massachusetts 01655 |
Northeast Alabama Regional Medical Center | Anniston, Alabama 36207 |
Veterans Affairs Medical Center - San Diego | San Diego, California 92161 |
UCSF Comprehensive Cancer Center | San Francisco, California 94115 |
Veterans Affairs Medical Center - Washington, DC | Washington, District of Columbia 20422 |
Memorial Regional Hospital Comprehensive Cancer Center | Hollywood, Florida 33021 |
Louis A. Weiss Memorial Hospital | Chicago, Illinois 60640 |
West Suburban Center for Cancer Care | River Forest, Illinois 60305 |
Saint Anthony Medical Center | Rockford, Illinois 61108 |
Fort Wayne Medical Oncology and Hematology, Incorporated | Fort Wayne, Indiana 46885-5099 |
Veterans Affairs Medical Center - Las Vegas | Las Vegas, Nevada 89106 |
Cooper University Hospital | Camden, New Jersey 08103 |
Elmhurst Hospital Center | Elmhurst, New York 11373 |
Queens Cancer Center of Queens Hospital | Jamaica, New York 11432 |
Veterans Affairs Medical Center - Asheville | Asheville, North Carolina 28805 |
NorthEast Oncology Associates | Concord, North Carolina 28025 |
Cape Fear Valley Health System | Fayetteville, North Carolina 28302-2000 |
Lenoir Memorial Hospital Cancer Center | Kinston, North Carolina 28503-1678 |
FirstHealth Moore Regional Hospital | Pinehurst, North Carolina 28374 |
New Hanover Regional Medical Center | Wilmington, North Carolina 28402-9025 |
Lifespan: The Miriam Hospital | Providence, Rhode Island 02906 |
University of Tennessee Cancer Institute | Memphis, Tennessee 38103 |
Veterans Affairs Medical Center - Dallas | Dallas, Texas 75216 |
Virginia Oncology Associates - Norfolk | Norfolk, Virginia 23502 |
St. Mary's Medical Center | Huntington, West Virginia 25701 |
Hematology Oncology Associates of the Quad Cities | Bettendorf, Iowa 52722 |
Vermont Cancer Center at University of Vermont | Burlington, Vermont 05405-0075 |
Lombardi Cancer Center at Georgetown University Medical Center | Washington, District of Columbia 20007 |
UNMC Eppley Cancer Center at the University of Nebraska Medical Center | Omaha, Nebraska 68198-7680 |
New Hampshire Oncology-Hematology, PA - Hooksett | Hooksett, New Hampshire 03106 |
Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph | Saint Joseph, Michigan 49085 |
New York Weill Cornell Cancer Center at Cornell University | New York, New York 10021 |
University Hospital at State University of New York - Upstate Medical University | Syracuse, New York 13210 |
Norris Cotton Cancer Center at Dartmouth Medical School | Lebanon, New Hampshire 03756-0002 |
Oklahoma University Medical Center at University of Oklahoma Health Sciences Center | Oklahoma City, Oklahoma 73126 |
Palm Beach Cancer Institute | West Palm Beach, Florida 33401 |