Recurrent Adult Acute Myeloid Leukemia Clinical Trial
Official title:
Phase I Trial of R115777 (NSC 702818) in Relapsed, Refractory or High Risk Myeloid Leukemia
Tipifarnib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. This phase I trial is studying the side effects and best dose of tipifarnib in treating patients with relapsed or refractory acute myeloid leukemia
PRIMARY OBJECTIVES:
I. To define the maximum tolerated dose (MTD) of R115777 (tipifarnib) in patients with
relapsed, refractory, or high risk myeloid leukemias treated according to this regimen.
II. To assess the toxicity and preliminary assessment of efficacy of R115777 in patients
with relapsed, refractory, or high risk myeloid leukemias.
OUTLINE: This is a dose-escalation, multicenter study.
Patients receive oral tipifarnib twice daily on days 1-7 and 15-21. Courses repeat every 28
days in the absence of unacceptable toxicity or disease progression. Patients achieving a
complete response (CR) receive 2 additional courses beyond CR. Patients experiencing relapse
after previously achieving CR may receive additional tipifarnib at the current dose level
for newly registered patients.
Cohorts of 3-6 patients receive escalating doses of tipifarnib until the MTD is determined.
The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience
dose-limiting toxicity.
Patients are followed every 6 months for survival.
PROJECTED ACCRUAL: A total of 20-30 patients will be accrued for this study.
;
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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