Clinical Trial: Tipifarnib in Treating Patients With Anemia or Neutropenia and Large Granular Lymphocyte Leukemia

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: A Phase 2 Study of Tipifarnib in Large Granular Lymphocyte (LGL) Leukemia

Brief Summary: This phase II trial is studying how well tipifarnib works in treating patients with anemia or neutropenia and large granular lymphocyte leukemia. 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.

Detailed Summary:

PRIMARY OBJECTIVES:

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.

SECONDARY OBJECTIVES:

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.

Sponsor: National Cancer Institute (NCI)

Current Primary Outcome: 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 ]

Original Primary Outcome:

Current Secondary Outcome: Changes in Ras/ERK and NK receptor expression [ Time Frame: Baseline to 5 years ]

Original Secondary Outcome:

Information By: National Cancer Institute (NCI)

Dates:
Date Received: August 3, 2006
Date Started: June 2, 2006
Date Completion:
Last Updated: April 4, 2017
Last Verified: April 2017