Interferon Alfa and Thalidomide in Treating Patients With Soft Tissue Sarcoma or Bone Sarcoma
|ClinicalTrials.gov Identifier: NCT00026416|
Recruitment Status : Unknown
Verified October 2003 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : January 27, 2003
Last Update Posted : January 6, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Sarcoma||Biological: recombinant interferon alfa Drug: thalidomide Procedure: adjuvant therapy||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||Phase II Study of Low-Dose Interferon Alfa 2B (Schering Plough) Plus Thalidomide (Celgene) for Patients With Resected High-Risk Soft Tissue Sarcoma|
|Study Start Date :||October 2001|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00026416
|United States, New York|
|Herbert Irving Comprehensive Cancer Center|
|New York, New York, United States, 10032|
|Study Chair:||Robert N. Taub, MD, PhD||Herbert Irving Comprehensive Cancer Center|