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Sponsors and Collaborators: |
Stanford University National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00005846 |
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.
Condition | Intervention | Phase |
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Leukemia Myelodysplastic/Myeloproliferative Diseases |
Drug: tipifarnib |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Phase I/II Study of the Farnesyltransferase Inhibitor R115777 (NSC 702818) in Patients With Myeloproliferative Disorders |
Study Start Date: | June 2000 |
OBJECTIVES:
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.
Ages Eligible for Study: | 21 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of chronic myelogenous leukemia (CML)
Must meet 1 of the following 2 conditions:
Chronic phase
Accelerated phase
Diagnosis of chronic myelomonocytic leukemia
No blast crisis phase of CML, atypical CML, or undifferentiated myeloproliferative disorders
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
No iron deficiency
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United States, California | |
Stanford Cancer Center at Stanford University Medical Center | |
Stanford, California, United States, 94305 | |
Veterans Affairs Medical Center - Palo Alto | |
Palo Alto, California, United States, 94304 | |
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 |
Study ID Numbers: | CDR0000067864, SUMC-NCI-38, NCI-38 |
Study First Received: | June 2, 2000 |
Last Updated: | April 18, 2009 |
ClinicalTrials.gov Identifier: | NCT00005846 History of Changes |
Health Authority: | United States: Federal Government |
relapsing chronic myelogenous leukemia chronic phase chronic myelogenous leukemia accelerated phase chronic myelogenous leukemia Philadelphia chromosome positive chronic myelogenous leukemia |
Philadelphia chromosome negative chronic myelogenous leukemia chronic myelomonocytic leukemia atypical chronic myeloid leukemia myelodysplastic/myeloproliferative disease, unclassifiable |
Philadelphia Chromosome Chronic Myelomonocytic Leukemia Hematologic Diseases Leukemia, Myelomonocytic, Chronic Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative Myeloproliferative Disorders Leukemia, Myeloid Leukemia, Myeloid, Chronic-Phase |
Leukemia Leukemia, Myeloid, Accelerated Phase Leukemia, Myelogenous, Chronic, BCR-ABL Positive Chronic Myelogenous Leukemia Myelodysplastic-Myeloproliferative Diseases Bone Marrow Diseases Myelodysplastic Myeloproliferative Disease Tipifarnib |
Leukemia Neoplasms Neoplasms by Histologic Type Antineoplastic Agents Hematologic Diseases Therapeutic Uses |
Myeloproliferative Disorders Bone Marrow Diseases Myelodysplastic-Myeloproliferative Diseases Pharmacologic Actions Tipifarnib |