Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002846
Status:
UNKNOWN
Last Update Posted:
2013-12-19
First Post:
1999-11-01
Brief Title:
Interleukin-2 in Treating Patients With Metastatic or Recurrent 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 LOW-DOSE INTRAVENOUS RECOMBINANT INTERLEUKIN-2
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 Interleukin-2 may stimulate a persons white blood cells to kill kidney cancer cells
PURPOSE Phase II trial to study the effectiveness of low-dose interleukin-2 in treating patients with metastatic or recurrent kidney cancer
PURPOSE Phase II trial to study the effectiveness of low-dose interleukin-2 in treating patients with metastatic or recurrent kidney cancer
Detailed Description:
OBJECTIVES
Assess the response rate and survival of patients with metastatic renal cell carcinoma treated with low-dose intravenous interleukin-2
Assess the toxicity associated with this treatment
OUTLINE Patients receive low-dose intravenous interleukin-2 every 8 hours for a maximum of 15 doses in week 1 and again in week 3 Stable and responding patients receive a second course beginning approximately 2 months after initiation of the first course Responding patients may continue therapy every 2 months provided toxicity is limited
Patients whose diseased kidney comprises the bulk of the tumor burden at entry undergo nephrectomy
Patients are followed for survival
PROJECTED ACCRUAL A total of 14 patients will be accrued for this study
Assess the response rate and survival of patients with metastatic renal cell carcinoma treated with low-dose intravenous interleukin-2
Assess the toxicity associated with this treatment
OUTLINE Patients receive low-dose intravenous interleukin-2 every 8 hours for a maximum of 15 doses in week 1 and again in week 3 Stable and responding patients receive a second course beginning approximately 2 months after initiation of the first course Responding patients may continue therapy every 2 months provided toxicity is limited
Patients whose diseased kidney comprises the bulk of the tumor burden at entry undergo nephrectomy
Patients are followed for survival
PROJECTED ACCRUAL A total of 14 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 |
|---|---|---|---|
| NCI-V96-1038 | None | None | None |
| CMC-09-95-15B | None | None | None |