NCT00026416

Interferon Alfa and Thalidomide in Treating Patients With Soft Tissue Sarcoma or Bone Sarcoma

Phase II Study of Low-Dose Interferon Alfa 2B (Schering Plough) Plus Thalidomide (Celgene) for Patients With Resected High-Risk Soft Tissue Sarcoma

• 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: Thalidomide may stop the growth of cancer by stopping blood flow to the tumor. Interferon alfa may interfere with the growth of cancer cells. Combining interferon alfa and thalidomide may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining interferon alfa and thalidomide in treating patients who have undergone surgery for soft tissue sarcoma or bone sarcoma.

Detailed description

OBJECTIVES: * Determine the efficacy of interferon alfa and thalidomide, in terms of time to disease progression, in patients with surgically resected high-risk soft tissue sarcoma or bone sarcoma. * Determine the incidence of metastatic disease and overall survival in patients treated with this regimen. * Determine the clinical and laboratory toxic effects and the tolerability of this regimen in these patients. OUTLINE: Patients receive interferon alfa subcutaneously three times a week on weeks 1-60 and oral thalidomide once daily on weeks 13-60 in the absence of disease progression or unacceptable toxicity. Patients are followed every 6 weeks for at least 2 years. PROJECTED ACCRUAL: A total of 20-48 patients will be accrued for this study.

Conditions

• Sarcoma

Interventions

Type	Name	Description
BIOLOGICAL	recombinant interferon alfa
DRUG	thalidomide
PROCEDURE	adjuvant therapy

Timeline

• Start date: 2001-10-01
• First posted: 2003-01-27
• Last updated: 2014-01-06

Locations

1 site across 1 country: United States