Tipifarnib in Treating Older Patients With Previously Untreated Acute Myeloid Leukemia

Completed · Phase 2

Conditions studied: Acute Myeloid Leukemia With Multilineage Dysplasia Following Myelodysplastic Syndrome, Adult Acute Basophilic Leukemia, Adult Acute Eosinophilic Leukemia, Adult Acute Erythroid Leukemia (M6), Adult Acute Megakaryoblastic Leukemia (M7), Adult Acute Minimally Differentiated Myeloid Leukemia (M0), Adult Acute Monoblastic Leukemia (M5a), Adult Acute Monoblastic Leukemia and Acute Monocytic Leukemia (M5), 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 Del(5q), 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), Cellular Diagnosis, Adult Acute Myeloid Leukemia, Untreated Adult Acute Myeloid Leukemia

In brief

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

Key facts

Study ID

NCT00027872

Run by

National Cancer Institute (NCI)

People needed

125

Starts

2001-10-01

Expected to finish

2009-01-01

Last updated by the study team

2013-03-25

Who can join

Age: 65 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Johns Hopkins University — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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