NCT00033709

Temozolomide and Thalidomide in Treating Patients With Metastatic, Locally Advanced, or Unresectable Leiomyosarcoma

A Phase II Study of Combination Therapy of a Protracted Oral Schedule of Temozolomide and Thalidomide as First-Line or Subsequent Therapy for Patients With Metastatic, Locally Advanced or Unresectable Leiomyosarcoma

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: —
• Sponsor: Herbert Irving Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Thalidomide may stop the growth of cancer by stopping blood flow to the tumor. Combining temozolomide with thalidomide may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining temozolomide with thalidomide in treating patients who have metastatic, locally advanced, or unresectable leiomyosarcoma.

Detailed description

OBJECTIVES: * Determine the efficacy of temozolomide and thalidomide in patients with metastatic, locally advanced, or unresectable leiomyosarcoma. * Determine the time to progression in patients treated with this regimen. * Determine the overall survival of patients treated with this regimen. * Determine the clinical and laboratory toxic effects and tolerability of this regimen in these patients. OUTLINE: Patients receive oral temozolomide once daily for 7 days every other week and oral thalidomide once daily. Treatment continues for up to 26 weeks in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A total of 15-25 patients will be accrued for this study within 7.5-25 months.

Conditions

• Sarcoma

Interventions

Type	Name	Description
DRUG	temozolomide
DRUG	thalidomide

Timeline

• Start date: 2002-03-01
• First posted: 2003-01-27
• Last updated: 2014-01-06

Locations

1 site across 1 country: United States