NCT00104988

S0508: Thalidomide and Temozolomide in Treating Patients With Stage IV Melanoma That Cannot Be Removed By Surgery

A Phase II Trial of Combination Thalidomide Plus Temozolomide in Patients With Metastatic Malignant Melanoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: SWOG Cancer Research Network · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Thalidomide may stop the growth of melanoma by blocking blood flow to the tumor. It may also stimulate the immune system in different ways and stop tumor cells from growing. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving thalidomide together with temozolomide may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving thalidomide together with temozolomide works in treating patients with stage IV melanoma that cannot be removed by surgery.

Detailed description

OBJECTIVES: * Determine the 6-month progression-free survival of patients with unresectable stage IV malignant cutaneous melanoma treated with thalidomide and temozolomide. * Determine the objective response (confirmed and unconfirmed complete response and partial response) in patients with measurable disease treated with this regimen. * Determine the overall survival of patients treated with this regimen. * Determine the qualitative and quantitative toxic effects of this regimen in these patients. OUTLINE: This is a multicenter study. Patients receive oral thalidomide once daily on days 1-56 and temozolomide once daily on days 1-42. Courses repeat every 56 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed at week 9, every 2 months until disease progression, and then every 6 months until 3 years from study entry. PROJECTED ACCRUAL: A total of 55 patients will be accrued for this study within 14 months.

Conditions

• Melanoma (Skin)

Interventions

Type	Name	Description
DRUG	temozolomide	75 mg/m\^2/day PO daily for 6 weeks followed by a 2-week break
DRUG	thalidomide	200 mg/day PO daily

Timeline

• Start date: 2005-06-01
• Primary completion: 2007-07-01
• Completion: 2009-08-01
• First posted: 2005-03-04
• Last updated: 2012-08-22

Locations

132 sites across 1 country: United States