Tipifarnib in Treating Older Patients With Acute Myeloid Leukemia (NCT01361464) | Clinical Trial Compass
CompletedPhase 2
Tipifarnib in Treating Older Patients With Acute Myeloid Leukemia
United States21 participantsStarted 2011-05
Plain-language 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.
Who can participate
Age range65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
What they're measuring
1
Complete Remission (CR) Rate
Timeframe: From first treatment through follow up period, an expected average of 12 months