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Sponsors and Collaborators: |
M.D. Anderson Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00005845 |
RATIONALE: Tipifarnib may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth.
PURPOSE: Phase I trial to study the effectiveness of tipifarnib in treating patients who have myelodysplastic syndrome.
Condition | Intervention | Phase |
---|---|---|
Leukemia Myelodysplastic Syndromes |
Drug: tipifarnib |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Phase I Study of the Farnesyl Transferase Inhibitor R115777 (NSC 702818) in Patients With Myelodysplastic Syndrome |
Study Start Date: | September 2000 |
Primary Completion Date: | December 2006 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a dose-escalation study.
Patients receive oral tipifarnib twice daily on weeks 1, 3, 5, and 7. Courses repeat every 8 weeks in the absence of unacceptable toxicity or disease progression.
Cohorts of 3-6 patients receive escalating doses of tipifarnib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. An additional 6 patients are then accrued to receive treatment at the MTD.
PROJECTED ACCRUAL: A total of 40-65 patients will be accrued for this study within 18 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed myelodysplastic syndromes including the following:
Patients with International Prognostic Scoring System score of 0 must have significant cytopenias of at least 4 weeks duration comprising at least one of the following:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United States, Texas | |
University of Texas - MD Anderson Cancer Center | |
Houston, Texas, United States, 77030-4009 |
Study Chair: | Razelle Kurzrock, MD | M.D. Anderson Cancer Center |
Study ID Numbers: | CDR0000067862, MDA-DM-99169, NCI-T99-0101, MDA-DM-01582, NCI-5625 |
Study First Received: | June 2, 2000 |
Last Updated: | August 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00005845 |
Health Authority: | United States: Federal Government |
refractory anemia refractory anemia with ringed sideroblasts refractory anemia with excess blasts refractory anemia with excess blasts in transformation chronic myelomonocytic leukemia |
de novo myelodysplastic syndromes previously treated myelodysplastic syndromes secondary myelodysplastic syndromes refractory cytopenia with multilineage dysplasia |
Myelodysplastic syndromes Precancerous Conditions Chronic myelomonocytic leukemia Refractory anemia Hematologic Diseases Leukemia, Myelomonocytic, Chronic Myelodysplastic Syndromes Myelodysplasia |
Anemia Leukemia Preleukemia Anemia, Refractory Neoplasm Metastasis Anemia, Refractory, with Excess of Blasts Bone Marrow Diseases Tipifarnib |
Neoplasms Pathologic Processes Disease Neoplasms by Histologic Type |
Antineoplastic Agents Therapeutic Uses Syndrome Pharmacologic Actions |