Leukemia Clinical Trial
Official title:
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)
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.
Status | Completed |
Enrollment | 60 |
Est. completion date | May 2005 |
Est. primary completion date | December 2004 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 17 Years and older |
Eligibility |
DISEASE CHARACTERISTICS: - One of the following diagnoses: - Primary refractory acute myeloid leukemia (AML) - More than 10% blasts in the bone marrow or blood after recovery from 2 courses of standard cytarabine- and anthracycline-based induction chemotherapy - No prior remission - Relapsed AML - More than 10% blasts in the bone marrow or blood after documented remission - Prior remission lasted more than 30 days - No prior treatment for current relapse - CD33 expression on at least 20% of leukemia blast cells at initial diagnosis for primary refractory patients or at the time of relapse for all other patients - No active CNS involvement PATIENT CHARACTERISTICS: Age: - 17 and over Performance status: - 0-2 Life expectancy: - Not specified Hematopoietic: - See Disease Characteristics - WBC less than 30,000/mm^3 Hepatic: - Bilirubin less than 2.0 mg/dL - No veno-occlusive disease of the liver - No chronic liver disease unless due to AML Renal: - Not specified Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No active serious infection PRIOR CONCURRENT THERAPY: Biologic therapy: - At least 6 months since prior stem cell transplantation Chemotherapy: - See Disease Characteristics - Prior etoposide and/or thioguanine during remission induction allowed - Prior hydroxyurea for control of AML allowed - At least 24 hours since prior hydroxyurea - At least 3 months since prior high-dose cytarabine (greater than 2 g/m^2/dose)-containing regimen - No other concurrent chemotherapy Endocrine therapy: - Concurrent steroids for adrenal failure, hypersensitivity reactions, or septic shock allowed - Concurrent ophthalmic corticosteroids allowed - Concurrent hormones for nondisease-related conditions (e.g., insulin for diabetes or estrogens or progestins for gynecologic conditions) allowed Radiotherapy: - No concurrent radiotherapy Surgery: - Not specified Other: - More than 2 months since prior cytotoxic therapy |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Puerto Rico | University of Puerto Rico School of Medicine Medical Sciences Campus | San Juan | |
United States | Northeast Alabama Regional Medical Center | Anniston | Alabama |
United States | Veterans Affairs Medical Center - Asheville | Asheville | North Carolina |
United States | Marlene and Stewart Greenebaum Cancer Center, University of Maryland | Baltimore | Maryland |
United States | Green Mountain Oncology Group | Bennington | Vermont |
United States | Hematology Oncology Associates of the Quad Cities | Bettendorf | Iowa |
United States | Veterans Affairs Medical Center - Birmingham | Birmingham | Alabama |
United States | Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | Boston | Massachusetts |
United States | Veterans Affairs Medical Center - Buffalo | Buffalo | New York |
United States | Vermont Cancer Center at University of Vermont | Burlington | Vermont |
United States | Cooper University Hospital | Camden | New Jersey |
United States | Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | Chapel Hill | North Carolina |
United States | Martha Jefferson Hospital | Charlottesville | Virginia |
United States | Louis A. Weiss Memorial Hospital | Chicago | Illinois |
United States | University of Chicago Cancer Research Center | Chicago | Illinois |
United States | Veterans Affairs Medical Center - Chicago (Westside Hospital) | Chicago | Illinois |
United States | Ellis Fischel Cancer Center at University of Missouri - Columbia | Columbia | Missouri |
United States | Veterans Affairs Medical Center - Columbia (Truman Memorial) | Columbia | Missouri |
United States | Arthur G. James Cancer Hospital - Ohio State University | Columbus | Ohio |
United States | NorthEast Oncology Associates | Concord | North Carolina |
United States | Veterans Affairs Medical Center - Dallas | Dallas | Texas |
United States | Duke Comprehensive Cancer Center | Durham | North Carolina |
United States | Veterans Affairs Medical Center - Durham | Durham | North Carolina |
United States | Elmhurst Hospital Center | Elmhurst | New York |
United States | Cape Fear Valley Health System | Fayetteville | North Carolina |
United States | Broward General Medical Center | Fort Lauderdale | Florida |
United States | Fort Wayne Medical Oncology and Hematology, Incorporated | Fort Wayne | Indiana |
United States | Memorial Regional Hospital Comprehensive Cancer Center | Hollywood | Florida |
United States | New Hampshire Oncology-Hematology, PA - Hooksett | Hooksett | New Hampshire |
United States | St. Mary's Medical Center | Huntington | West Virginia |
United States | Holden Comprehensive Cancer Center at University of Iowa | Iowa City | Iowa |
United States | Queens Cancer Center of Queens Hospital | Jamaica | New York |
United States | CCOP - Kansas City | Kansas City | Missouri |
United States | Lenoir Memorial Hospital Cancer Center | Kinston | North Carolina |
United States | Rebecca and John Moores UCSD Cancer Center | La Jolla | California |
United States | CCOP - Southern Nevada Cancer Research Foundation | Las Vegas | Nevada |
United States | Veterans Affairs Medical Center - Las Vegas | Las Vegas | Nevada |
United States | Norris Cotton Cancer Center at Dartmouth Medical School | Lebanon | New Hampshire |
United States | Baptist Hospital East - Louisville | Louisville | Kentucky |
United States | CCOP - North Shore University Hospital | Manhasset | New York |
United States | North Shore University Hospital | Manhasset | New York |
United States | University of Tennessee Cancer Institute | Memphis | Tennessee |
United States | Veterans Affairs Medical Center - Memphis | Memphis | Tennessee |
United States | CCOP - Mount Sinai Medical Center | Miami Beach | Florida |
United States | University of Minnesota Cancer Center | Minneapolis | Minnesota |
United States | Veterans Affairs Medical Center - Minneapolis | Minneapolis | Minnesota |
United States | Memorial Sloan-Kettering Cancer Center | New York | New York |
United States | Mount Sinai Medical Center, NY | New York | New York |
United States | New York Weill Cornell Cancer Center at Cornell University | New York | New York |
United States | CCOP - Christiana Care Health Services | Newark | Delaware |
United States | Virginia Oncology Associates - Norfolk | Norfolk | Virginia |
United States | Oklahoma University Medical Center at University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma |
United States | UNMC Eppley Cancer Center at the University of Nebraska Medical Center | Omaha | Nebraska |
United States | Florida Hospital Cancer Institute | Orlando | Florida |
United States | CCOP - Illinois Oncology Research Association | Peoria | Illinois |
United States | FirstHealth Moore Regional Hospital | Pinehurst | North Carolina |
United States | Lifespan: The Miriam Hospital | Providence | Rhode Island |
United States | MBCCOP - Massey Cancer Center | Richmond | Virginia |
United States | West Suburban Center for Cancer Care | River Forest | Illinois |
United States | Oncology and Hematology Associates of Southwest Virginia, Inc. | Roanoke | Virginia |
United States | Saint Anthony Medical Center | Rockford | Illinois |
United States | Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph | Saint Joseph | Michigan |
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 | Barnes-Jewish Hospital | St. Louis | Missouri |
United States | CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C. | Syracuse | New York |
United States | University Hospital at State University of New York - Upstate Medical University | Syracuse | New York |
United States | Veterans Affairs Medical Center - Syracuse | Syracuse | New York |
United States | Lombardi Cancer Center at Georgetown University Medical Center | Washington | District of Columbia |
United States | Veterans Affairs Medical Center - Washington, DC | Washington | District of Columbia |
United States | Walter Reed Army Medical Center | Washington | District of Columbia |
United States | Palm Beach Cancer Institute | West Palm Beach | Florida |
United States | Veterans Affairs Medical Center - White River Junction | White River Junction | Vermont |
United States | New Hanover Regional Medical Center | Wilmington | North Carolina |
United States | CCOP - Southeast Cancer Control Consortium | Winston-Salem | North Carolina |
United States | Comprehensive Cancer Center at Wake Forest University | Winston-Salem | North Carolina |
United States | University of Massachusetts Memorial Medical Center - University Campus | Worcester | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Alliance for Clinical Trials in Oncology | National Cancer Institute (NCI) |
United States, Puerto Rico,
Stone RM, Moser B, Sanford B, Schulman P, Kolitz JE, Allen S, Stock W, Galinsky I, Vij R, Marcucci G, Hurd D, Larson RA; Cancer and Leukemia Group B. High dose cytarabine plus gemtuzumab ozogamicin for patients with relapsed or refractory acute myeloid le — View Citation
Stone RM, Moser B, Schulman P, et al.: A dose escalation and phase II study of gemtuzumab ozogamicin (GO) with high-dose cytarabine (HiDAC) for patients (pts) with refractory or relapsed acute myeloid leukemia (AML): CALGB 19902. [Abstract] Blood 104 (11)
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Complete remission rate | 8 or 14 days after tx initiation & 30 d post tx | No | |
Secondary | Toxicity | D 14, then 30, 60 , & 90 d post Tx, q 3 mon for 1 yr, then at relapse or death | Yes |
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