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Sponsors and Collaborators: |
Case Comprehensive Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00360776 |
RATIONALE: Tipifarnib may stop the growth of leukemia by blocking blood flow to the cancer cells and by blocking some of the enzymes needed for cancer cell growth.
PURPOSE: This phase II trial is studying how well tipifarnib works in treating patients with anemia or neutropenia and large granular lymphocyte leukemia.
Condition | Intervention | Phase |
---|---|---|
Cancer-Related Problem/Condition Leukemia |
Drug: tipifarnib Procedure: laboratory biomarker analysis Procedure: mutation analysis |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Study of R115777 in Large Granular Lymphocyte (LGL) Leukemia Bone Marrow Failure Diseases Consortium |
Estimated Enrollment: | 56 |
Study Start Date: | June 2006 |
Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Secondary
OUTLINE: This is a multicenter study. Patients are stratified by disease type (natural killer-large granular lymphocyte [LGL] leukemia vs T-cell-LGL leukemia).
Patients receive oral tipifarnib twice daily on days 1-21. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients are evaluated after completion of course 4. Patients achieving complete response receive 1 additional course of treatment. Patients achieving partial response receive 4 additional courses of treatment in the absence of disease progression or unacceptable toxicity.
Patients undergo blood collection periodically during study for response mechanism studies and other biomarker correlative studies, including mutations of K-ras and N-ras genes.
After completion of study treatment, patients are followed every 6 months for 5 years.
PROJECTED ACCRUAL: A total of 56 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of T-cell-large granular lymphocyte (LGL) leukemia or natural killer (NK)-LGL leukemia associated with ≥ 1 of the following clinical manifestations:
Neutropenia associated with recurrent infections, meeting 1 of the following criteria:
Symptomatic anemia with any of the following:
T-cell-LGL leukemia must meet all of the following criteria:
PATIENT CHARACTERISTICS:
No uncontrolled concurrent illness including, but not limited to, any of the following:
PRIOR CONCURRENT THERAPY:
United States, Florida | |
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida | |
Tampa, Florida, United States, 33612-9497 | |
United States, Ohio | |
Cleveland Clinic Taussig Cancer Center | |
Cleveland, Ohio, United States, 44195 | |
United States, Pennsylvania | |
Penn State Cancer Institute at Milton S. Hershey Medical Center | |
Hershey, Pennsylvania, United States, 17033-0850 |
Study Chair: | Thomas P. Loughran, MD | Milton S. Hershey Medical Center |
Study ID Numbers: | CDR0000489291, CASE-4202, NCI-6823, CASE-RDN-5402 |
Study First Received: | August 3, 2006 |
Last Updated: | December 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00360776 |
Health Authority: | United States: Food and Drug Administration |
T-cell large granular lymphocyte leukemia anemia neutropenia |
Neutropenia Leukemia Large granular lymphocyte leukemia |
Anemia Pancytopenia Tipifarnib |
Neoplasms Neoplasms by Histologic Type Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |