Tipifarnib, Cytarabine, and Daunorubicin in Treating Older Patients With Acute Myeloid Leukemia
Leukemia
About this trial
This is an interventional treatment trial for Leukemia focused on measuring adult acute basophilic leukemia, adult acute eosinophilic leukemia, adult acute megakaryoblastic leukemia (M7), adult acute minimally differentiated myeloid leukemia (M0), adult acute monoblastic leukemia (M5a), adult acute monocytic leukemia (M5b), adult acute myeloblastic leukemia with maturation (M2), adult acute myeloblastic leukemia without maturation (M1), adult acute myeloid leukemia with 11q23 (MLL) abnormalities, adult acute myeloid leukemia with inv(16)(p13;q22), adult acute myeloid leukemia with t(16;16)(p13;q22), adult acute myeloid leukemia with t(8;21)(q22;q22), adult acute myelomonocytic leukemia (M4), adult erythroleukemia (M6a), adult pure erythroid leukemia (M6b), untreated adult acute myeloid leukemia
Eligibility Criteria
DISEASE CHARACTERISTICS: Diagnosis of acute myeloid leukemia (AML) All subtypes, except acute promyelocytic leukemia, are allowed At least 20% bone marrow or peripheral blood blasts OR biopsy-confirmed extramedullary disease No cerebrospinal fluid involvement PATIENT CHARACTERISTICS: Age 56 and over Performance status ECOG 0-2 OR Karnofsky 60-100% Life expectancy Not specified Hematopoietic See Disease Characteristics WBC < 100,000/mm^3 (treatment with hydroxyurea allowed) Hepatic Bilirubin ≤ 1.25 times upper limit of normal (ULN) AST and ALT ≤ 2.0 times ULN Renal Creatinine < 1.7 mg/dL OR Creatinine clearance ≥ 60 mL/min Cardiovascular LVEF ≥ 50% No symptomatic congestive heart failure No unstable angina pectoris No cardiac arrhythmia Immunologic HIV negative No history of allergic reaction attributed to compounds of similar chemical or biologic composition to tipifarnib or imidazole drugs (e.g., ketoconazole, clotrimazole, or miconazole) No ongoing or active infection Other Not pregnant Fertile patients must use effective contraception Able to swallow oral medications No other uncontrolled illness No psychiatric illness or social situation that would preclude study compliance PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy No prior chemotherapy for AML except hydroxyurea for cytoreduction More than 4 weeks since prior chemotherapy except hydroxyurea (6 weeks for nitrosoureas or mitomycin) and recovered At least 24 hours since prior hydroxyurea Endocrine therapy No concurrent dexamethasone Radiotherapy More than 4 weeks since prior radiotherapy and recovered No prior radiotherapy > 3,000 cGy to marrow-producing areas Surgery Not specified Other No other concurrent investigational agents No other concurrent antileukemic agents No concurrent treatment with any of the following: Ketoconazole Itraconazole Voriconazole Clarithromycin Erythromycin Phenytoin Carbamazepine Barbiturates Cyclosporine Pimozide Warfarin Grapefruit juice Simvastatin Lovastatin Atorvastatin No concurrent magnesium- or aluminum-containing antacids within 2 hours before or after tipifarnib administration
Sites / Locations
- McMaster Children's Hospital at Hamilton Health Sciences
- London Regional Cancer Program at London Health Sciences Centre
Arms of the Study
Arm 1
Experimental
Tipifarnib with conventional induction and consolidation