Leukemia Clinical Trial
Official title:
Phase I/II Study of the Farnesyltransferase Inhibitor R115777 (NSC 702818) in Patients With Myeloproliferative Disorders
RATIONALE: Tipifarnib may stop the growth of cancer cells by blocking the enzymes necessary
for cancer cell growth.
PURPOSE: This phase I/II trial is studying the side effects of tipifarnib and to see how
well it works in treating patents with myeloproliferative disorders.
OBJECTIVES:
- Determine the toxic effects of tipifarnib in adult patients with myeloproliferative
disorders.
- Determine hematological responses, including changes in WBC count and erythroid
responses, in this patient population treated with this drug.
- Determine the cytogenetic response in bone marrow of patients treated with this drug.
OUTLINE: This is a multicenter study. Patients are stratified according to prior substantive
treatment (yes vs no).
Patients receive oral tipifarnib twice daily on days 1-21. Treatment repeats every 4 weeks
for a maximum of 4 courses in the absence of unacceptable toxicity or disease progression.
Patients with continued hematologic response after completion of the fourth course may
receive additional courses at the discretion of the investigator.
PROJECTED ACCRUAL: A total of 25 patients (12-13 per stratum) will be accrued for this study
within 25 months.
;
Primary Purpose: Treatment
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