Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002847
Status:
UNKNOWN
Last Update Posted:
2013-12-19
First Post:
1999-11-01
Brief Title:
Interferon Alfa and Interleukin-2 in Treating Patients With Metastatic Kidney Cancer
Sponsor:
Blumenthal Cancer Center at Carolinas Medical Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
TREATMENT OF METASTATIC RENAL CELL CARCINOMA WITH SUBCUTANEOUS RECOMBINANT INTERLEUKIN-2 AND INTERFERON ALPHA
Status:
UNKNOWN
Status Verified Date:
2003-12
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 Biological therapies use different ways to stimulate the immune system to try to stop cancer cells from growing Combining interferon alfa and interleukin-2 may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of interferon alfa and interleukin-2 in treating patients with metastatic kidney cancer
PURPOSE Phase II trial to study the effectiveness of interferon alfa and interleukin-2 in treating patients with metastatic kidney cancer
Detailed Description:
OBJECTIVES
Evaluate the response and disease-free survival of patients with metastatic renal cell carcinoma treated with subcutaneous interleukin-2 and interferon alfa
Assess the toxicity of this regimen
OUTLINE Patients undergo nephrectomy if the diseased kidney makes up the bulk of the tumor burden
All patients receive subcutaneous interferon alfa on day 1 and interleukin-2 on days 3-5 of week 1 followed by reduced doses of interferon alfa and interleukin-2 on days 1 3 and 5 of weeks 2-6 Patients are assessed for response approximately 2 months after initiating therapy Patients with stable or responding disease undergo a second course those who continue to respond may receive additional therapy provided toxicity is limited
Patients are followed for survival
PROJECTED ACCRUAL 14 patients will be entered
Evaluate the response and disease-free survival of patients with metastatic renal cell carcinoma treated with subcutaneous interleukin-2 and interferon alfa
Assess the toxicity of this regimen
OUTLINE Patients undergo nephrectomy if the diseased kidney makes up the bulk of the tumor burden
All patients receive subcutaneous interferon alfa on day 1 and interleukin-2 on days 3-5 of week 1 followed by reduced doses of interferon alfa and interleukin-2 on days 1 3 and 5 of weeks 2-6 Patients are assessed for response approximately 2 months after initiating therapy Patients with stable or responding disease undergo a second course those who continue to respond may receive additional therapy provided toxicity is limited
Patients are followed for survival
PROJECTED ACCRUAL 14 patients will be entered
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 |
|---|---|---|---|
| NCI-V96-1039 | None | None | None |
| CMC-09-95-14B | None | None | None |