Tipifarnib in Treating Older Patients With Previously Untreated Acute Myeloid Leukemia
Acute Myeloid Leukemia With Multilineage Dysplasia Following Myelodysplastic Syndrome, Adult Acute Basophilic Leukemia, Adult Acute Eosinophilic Leukemia
About this trial
This is an interventional treatment trial for Acute Myeloid Leukemia With Multilineage Dysplasia Following Myelodysplastic Syndrome
Eligibility Criteria
Inclusion Criteria: Pathologic confirmation of the diagnosis of AML (>= 20% marrow blasts) ECOG performance status 0 or 1 Patients must be able to give informed consent SGOT and SGPT =< 2.5 x normal limits (grade 1) Serum creatinine =< 1.5 x normal limits (grade 1) AML (any of the following): Newly diagnosed AML in adults >= 75 years Newly diagnosed AML arising from MDS in adults >= 65 years Hyperleukocytosis with >= 30,000 leukemic blasts/uL Exclusion Criteria: Acute promyelocytic (FAB M3) subtype Previously treated with chemotherapy for leukemia (except for hydroxyurea) Disseminated intravascular coagulation (laboratory or clinical) Active central nervous system leukemia Concomitant radiation therapy, chemotherapy, or immunotherapy; previous therapy for another malignancy is permitted, provided that at least 1 month has occurred since patient received any of these treatments Intrinsic impaired organ function (as stated above) Symptomatic neuropathy (grade 2 or worse) Known allergy to imidazole drugs, such as ketoconazole, miconazole, econazole, teconazole, clotrimazole, fenticonazole, isoconazole, sulconazole, or ticonazole Physical or psychiatric conditions that in the estimation of the principal investigator (PI) or designee place the patient at high risk of toxicity or non-compliance, e.g. severe congestive heart failure (CHF), unstable angina, or poorly controlled psychosis
Sites / Locations
- Johns Hopkins University
Arms of the Study
Arm 1
Experimental
Treatment (tipifarnib)
Patients receive oral tipifarnib twice daily on days 1-21. Patients with a complete or partial response, hematologic improvement, or stable disease continue treatment every 29-63 days in the absence of disease progression or unacceptable toxicity. Patients with a complete response after the second course of therapy receive 2 additional courses of therapy.