Tipifarnib in Treating Older Patients With Acute Myeloid Leukemia

Completed · Phase 2

Conditions studied: Adult Acute Megakaryoblastic Leukemia, Adult Acute Monoblastic Leukemia, Adult Acute Monocytic Leukemia, Adult Acute Myeloid Leukemia With Inv(16)(p13.1q22); CBFB-MYH11, Adult Acute Myeloid Leukemia With Maturation, Adult Acute Myeloid Leukemia With Minimal Differentiation, Adult Acute Myeloid Leukemia With t(16;16)(p13.1;q22); CBFB-MYH11, Adult Acute Myeloid Leukemia With t(8;21)(q22;q22); RUNX1-RUNX1T1, Adult Acute Myeloid Leukemia With t(9;11)(p22;q23); MLLT3-MLL, Adult Acute Myeloid Leukemia Without Maturation, Adult Acute Myelomonocytic Leukemia, Adult Erythroleukemia, Adult Pure Erythroid Leukemia, Alkylating Agent-Related Acute Myeloid Leukemia, Secondary Acute Myeloid Leukemia, Untreated Adult Acute Myeloid Leukemia

In brief

This phase II trial is studying how well tipifarnib works in treating older patients with acute myeloid leukemia. Tipifarnib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

Key facts

Study ID

NCT01361464

Run by

National Cancer Institute (NCI)

People needed

21

Starts

2011-05-01

Expected to finish

2014-11-01

Last updated by the study team

2015-04-08

Who can join

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

You may qualify if…

• Previously untreated acute myeloid leukemia (AML) (de novo or secondary)
• No diagnosis of acute promyelocytic leukemia (APL)
• Deemed unsuitable for or refuses standard induction chemotherapy
• RASGRP1:APTX ratio >= 5, through bone marrow screening
• No patients with known leukemic involvement of the central nervous system
• ECOG performance status =< 2
• No WBC >= 30,000/uL (hydroxyurea permitted up to 24 hours prior to initiation of therapy)
• Serum creatinine less than 1.5 times the upper limit of the normal range (ULN) (National Cancer Institute [NCI] Common Toxicity Criteria [CTC] Grade 1)
• Total bilirubin less than 1.5 times ULN (unless the increase is unequivocally due to hemolysis or Gilbert syndrome)
• ALT and AST less than 2.5 times ULN (NCI CTC Grade 1)
• Men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation
• No symptomatic neuropathy of grade 2 or worse
• No uncompensated disseminated intravascular coagulation (DIC) or uncontrolled bleeding
• No history of allergic reactions attributed to compounds of similar chemical or biologic composition to tipifarnib (R115777), such as the imidazole drugs, including clotrimazole, ketoconazole, miconazole, econazole, fenticonazole, isoconazole, sulconazole, ticonazole, or terconazole
• No uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• Known HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with R115777; in addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy; known HIV-positive patients NOT on antiretroviral therapy AND with a CD4 cell count >= 400/mm\^3 are eligible
• No other concurrent cytotoxic or biologic antileukemic therapy
• No patients who are receiving any other investigational agents
• Use of enzyme-inducing anticonvulsants (e.g., phenytoin, fosphenytoin, phenobarbital, primidone, carbamazepine, oxcarbazepine) while taking tipifarnib (R115777) is contraindicated
• If clinically indicated, subjects may use non-enzyme-inducing anticonvulsants during treatment with R115777

Where it is running

• Moffitt Cancer Center — Tampa, Florida, United States
• Emory University/Winship Cancer Institute — Atlanta, Georgia, United States
• Blood and Marrow Transplant Group of Georgia — Atlanta, Georgia, United States
• Johns Hopkins University/Sidney Kimmel Comprehensive Cancer Center — Baltimore, Maryland, United States
• Memorial Sloan-Kettering Cancer Center — New York, New York, United States
• Weill Medical College of Cornell University — New York, New York, United States
• University of North Carolina — Chapel Hill, North Carolina, United States

Full record on ClinicalTrials.gov

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