Tipifarnib in Treating Patients With Anemia or Neutropenia and Large Granular Lymphocyte Leukemia
Stage III Chronic Lymphocytic Leukemia
Stage IV Chronic Lymphocytic Leukemia
T-cell Large Granular Lymphocyte Leukemia
Other: laboratory biomarker analysis
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase 2 Study of Tipifarnib in Large Granular Lymphocyte (LGL) Leukemia|
- Response rates to tipifarib defined as the proportion of patients achieving a complete response (CCR) or partial response (PR) [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
- Changes in Ras/ERK and NK receptor expression [ Time Frame: Baseline to 5 years ] [ Designated as safety issue: No ]
|Study Start Date:||June 2006|
|Primary Completion Date:||April 2009 (Final data collection date for primary outcome measure)|
Experimental: Arm I
Patients will receive tipifarnib by mouth twice a day for 3 weeks. Treatment may repeat every 4 weeks for up to eight courses.
Patients will undergo blood collection periodically for laboratory studies. After finishing treatment, patients will be evaluated every 6 months for 5 years.
Other Names:Other: laboratory biomarker analysis
I. Estimate the complete response rate, partial response rate, and overall response rate in patients with natural killer (NK)- or T-cell-large granular lymphocyte (LGL) leukemia who present with neutropenia or anemia treated with tipifarnib.
I. Determine the toxicity of tipifarnib in these patients. II. Determine the mechanism of treatment responses in these patients through correlative laboratory studies.
OUTLINE: 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00360776
|United States, Ohio|
|Case Western Reserve University|
|Cleveland, Ohio, United States, 44106|
|Principal Investigator:||Thomas Loughran||Case Comprehensive Cancer Center|