NCT00060125

Tipifarnib in Treating Patients With Metastatic Malignant Melanoma

PHASE II TRIAL OF R115777 IN PATIENTS WITH METASTATIC MALIGNANT MELANOMA

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial is studying how well tipifarnib works in treating patients with metastatic malignant melanoma. Tipifarnib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth.

Detailed description

PRIMARY OBJECTIVES: 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. SECONDARY OBJECTIVES: 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.

Conditions

• Recurrent Melanoma
• Stage IV Melanoma

Interventions

Type	Name	Description
DRUG	tipifarnib	Given orally
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2003-05-01
• Primary completion: 2006-06-01
• First posted: 2003-05-07
• Last updated: 2013-06-05

Locations

1 site across 1 country: United States