Tipifarnib in Treating Older Patients With Acute Myeloid Leukemia
Condition: 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
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Leukemia, Monocytic, Acute; Leukemia, Myelomonocytic, Acute; Leukemia, Megakaryoblastic, Acute; Leukemia, Erythroblastic, Acute
Intervention: Tipifarnib; Laboratory Biomarker Analysis
Intervention description: Given PO; Correlative studies
Intervention MeSH terms: Tipifarnib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 21.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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