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S0535, Gemtuzumab and Combination Chemotherapy in Treating Patients With Previously Untreated Acute Promyelocytic Leukemia
Not Recruiting
Trial ID: NCT00551460
Purpose
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer
cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies,
such as gemtuzumab, can block cancer growth in different ways. Some find cancer cells and
help kill them or carry cancer-killing substances to them. Others interfere with the ability
of cancer cells to grow and spread. Gemtuzumab may also stop the growth of promyelocytic
leukemia by blocking blood flow to the cancer. Giving gemtuzumab together with combination
chemotherapy may be more effective in treating promyelocytic leukemia.
PURPOSE: This phase II trial is studying how well giving gemtuzumab together with combination
chemotherapy works in treating patients with previously untreated promyelocytic leukemia.
Official Title
S0535, A Phase II Study of ATRA, Arsenic Trioxide and Gemtuzumab Ozogamicin in Patients With Previously Untreated High-Risk Acute Promyelocytic Leukemia
Stanford Investigator(s)
Jason Gotlib
Professor of Medicine (Hematology)
Rondeep Brar
Clinical Associate Professor, Medicine - Hematology
Lauren Maeda
Clinical Associate Professor, Medicine - Oncology
Caroline Berube
Clinical Associate Professor, Medicine - Hematology
Eligibility
DISEASE CHARACTERISTICS:
- Morphologically confirmed acute promyelocytic leukemia (APL) based on bone marrow
examination
- APL-RARα-negative by RT-PCR are not eligible
- High-risk disease, defined as WBC > 100,000/mm^3
- Bone marrow specimens must be made available for cytogenetic studies
PATIENT CHARACTERISTICS:
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No prolonged QTc > 0.47 sec
- No other malignancy within the past 5 years, except adequately treated basal cell or
squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated
stage I or stage II cancer from which the patients is currently in complete remission
PRIOR CONCURRENT THERAPY:
- No prior systemic chemotherapy for acute leukemia
- At least 3 days since prior tretinoin (ATRA) allowed
- Prior hydroxyurea, corticosteroids, or leukapheresis to control high cell counts
allowed
Intervention(s):
drug: arsenic trioxide
drug: gemtuzumab ozogamicin
drug: mercaptopurine
drug: methotrexate
drug: tretinoin
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Cancer Clinical Trials Office
650-498-7061