Tipifarnib in Treating Patients With Metastatic Malignant Melanoma
|Recurrent Melanoma Stage IV Melanoma||Drug: tipifarnib Other: laboratory biomarker analysis||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||PHASE II TRIAL OF R115777 IN PATIENTS WITH METASTATIC MALIGNANT MELANOMA|
- Response rate (complete response [CR] and partial response [PR]} [ Time Frame: Up to 2 years ]Estimated confidence intervals will be adjusted for the number of stages.
- Progression-free survival (PFS) [ Time Frame: From date of entry onto the trial until documented progression or death from any cause, assessed up to 2 years ]Estimated using the method of Kaplan and Meier.
- Time to treatment failure (TTF) [ Time Frame: From trial entry until a patient ends protocol therapy due to unacceptable toxicity, progression or death from any cause, assessed up to 2 years ]Estimated using the method of Kaplan and Meier.
- Correlation between RhoC expression levels and response [ Time Frame: From baseline to up to 2 years ]
- Change in FTAse levels [ Time Frame: From baseline to up to 2 years ]
- Change in the production of IL-2 and IFN-g by T cells [ Time Frame: From baseline to up to 2 years ]Descriptive statistics will be used to describe the mean and spread of production of IL-2 and IFN-g.
- Adverse events as assessed by Common Toxicity Criteria (CTC) version 2.0 [ Time Frame: Up to 2 years ]
|Study Start Date:||May 2003|
|Primary Completion Date:||June 2006 (Final data collection date for primary outcome measure)|
Experimental: Treatment (tipifarnib)
Patients receive oral tipifarnib twice daily on days 1-21. Treatment repeats every 28 days for at least 2 courses and for a maximum of 2 years in the absence of disease progression or unacceptable toxicity. Patients who achieve CR receive 2 additional courses beyond CR.
Other Names:Other: laboratory biomarker analysis
I. To estimate the clinical response rate in patients with metastatic malignant melanoma treated with R115777 (tipifarnib).
II. To evaluate the safety of R115777 in patients with metastatic melanoma.
I. To assess RhoC expression in tumor samples pre- and post- therapy with R115777.
II. To evaluate Ftase levels in peripheral blood and tumor samples pre- and post-therapy with R115777.
III. To assess the effect of R115777 treatment on T lymphocyte cytokine production, pre- and post- therapy with R115777.
IV. Estimate time to treatment failure (TTF). Time to treatment failure is defined as time to withdrawal for unacceptable toxicity or progressive disease.
OUTLINE Patients receive oral tipifarnib twice daily on days 1-21. Treatment repeats every 28 days for at least 2 courses and for a maximum of 2 years in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response (CR) receive 2 additional courses beyond CR.
Patients who discontinue therapy due to toxicity or complete response are followed every 3 months for 2 years after study entry. Patients who discontinue therapy due to disease progression are followed every 6 months for 2 years after study entry. Patients with stable or partially responding disease who complete treatment are followed at 2 years after study entry.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00060125
|United States, Illinois|
|Cancer and Leukemia Group B|
|Chicago, Illinois, United States, 60606|
|Principal Investigator:||Thomas Gajewski||Cancer and Leukemia Group B|