Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00026416
Status:
UNKNOWN
Last Update Posted:
2014-01-06
First Post:
2001-11-09
Brief Title:
Interferon Alfa and Thalidomide in Treating Patients With Soft Tissue Sarcoma or Bone Sarcoma
Sponsor:
Herbert Irving Comprehensive Cancer Center
Organization:
National Cancer Institute NCI
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2003-10
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CPMC-IRB-13887 | None | None | None |
| NCI-G01-2024 | None | None | None |