Tipifarnib in Treating Patients With Myeloproliferative Disorders
Recruitment status was: Active, not recruiting
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.
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Phase I/II Study of the Farnesyltransferase Inhibitor R115777 (NSC 702818) in Patients With Myeloproliferative Disorders|
|Study Start Date:||June 2000|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005846
|United States, California|
|Veterans Affairs Medical Center - Palo Alto|
|Palo Alto, California, United States, 94304|
|Stanford Cancer Center at Stanford University Medical Center|
|Stanford, California, United States, 94305|
|United States, New York|
|James P. Wilmot Cancer Center at University of Rochester Medical Center|
|Rochester, New York, United States, 14642|
|Study Chair:||Peter L. Greenberg, MD||Stanford University|