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

Phase 2
Conditions
Sarcoma
Registration Number
NCT00033709
Lead Sponsor
Herbert Irving Comprehensive Cancer Center
Brief 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.

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
Not specified
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Response (complete and partial response)
Secondary Outcome Measures
NameTimeMethod
Time to progression
Clinical benefit
Overall survival

Trial Locations

Locations (1)

Herbert Irving Comprehensive Cancer Center at Columbia University

🇺🇸

New York, New York, United States

Herbert Irving Comprehensive Cancer Center at Columbia University
🇺🇸New York, New York, United States

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