Tipifarnib in Treating Older Patients With Previously Untreated Acute Myeloid Leukemia

• Status: Completed
• Trial end date: 2009-01-01
• Target enrollment: 0
• Participant gender: All

Summary

Tipifarnib may stop the growth of cancer cells by blocking the enzymes necessary for their growth. Phase II trial to study the effectiveness of tipifarnib in treating older patients who have previously untreated acute myeloid leukemia

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Tipifarnib

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