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Clinical Trial Summary

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.


Clinical Trial Description

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. ;


Study Design

Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00005846
Study type Interventional
Source National Cancer Institute (NCI)
Contact
Status Active, not recruiting
Phase Phase 1/Phase 2
Start date June 2000

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