Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003604
Status:
UNKNOWN
Last Update Posted:
2013-11-06
First Post:
1999-11-01
Brief Title:
Interleukin-2 in Treating Patients With Stage III or Stage IV Kidney Cancer That Has Been Removed With Surgery
Sponsor:
Cancer Biotherapy Research Group
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Multi-Center Adjuvant Trial of Outpatient Moderate-Dose Bolus Interleukin-2 for Renal Cancer
Status:
UNKNOWN
Status Verified Date:
2000-09
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 interleukin-2 in treating patients with stage III or stage IV kidney cancer that has been removed by surgery
PURPOSE Phase II trial to study the effectiveness of interleukin-2 in treating patients with stage III or stage IV kidney cancer that has been removed by surgery
Detailed Description:
OBJECTIVES I Determine the disease free survival and overall survival of patients with resected stage III or IV renal cancer treated with interleukin-2 II Measure the degree of rebound lymphocytosis generated by this regimen in these patients
OUTLINE This is an open label study Patients receive interleukin-2 IV over 15-30 minutes on 3 consecutive days weekly for 6 weeks followed by 2 weeks of rest Patients receive 2 treatment courses each 8 weeks in duration Patients are followed every 6 months until death
PROJECTED ACCRUAL A total of 20 patients will be accrued within 1 to 2 years
OUTLINE This is an open label study Patients receive interleukin-2 IV over 15-30 minutes on 3 consecutive days weekly for 6 weeks followed by 2 weeks of rest Patients receive 2 treatment courses each 8 weeks in duration Patients are followed every 6 months until death
PROJECTED ACCRUAL A total of 20 patients will be accrued within 1 to 2 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-V98-1482 | None | None | None |
| CBRG-9704 | None | None | None |
| NBSG-9704 | None | None | None |