Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002845
Status:
UNKNOWN
Last Update Posted:
2013-12-19
First Post:
1999-11-01
Brief Title:
Interleukin-2 in Treating Patients With Metastatic Melanoma
Sponsor:
Blumenthal Cancer Center at Carolinas Medical Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
TREATMENT OF METASTATIC MELANOMA WITH RECOMBINANT INTERLEUKIN-2
Status:
UNKNOWN
Status Verified Date:
2000-05
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 melanoma cells
PURPOSE Phase II trial to study the effectiveness of interleukin-2 in treating patients who have metastatic melanoma
PURPOSE Phase II trial to study the effectiveness of interleukin-2 in treating patients who have metastatic melanoma
Detailed Description:
OBJECTIVES I Evaluate the response and survival rates of patients with metastatic melanoma following induction with high-dose and maintenance with low-dose interleukin-2 II Assess the toxicity of this regimen
OUTLINE All patients receive high-dose interleukin-2 over 24 hours followed by low-dose interleukin-2 for 4 days in the absence of toxicity Patients receive a second cycle beginning 9-13 days after completion of the first cycle with response assessed approximately 2 months after initiating therapy Patients with stable or responding disease receive a second course as above those with a continued response may receive additional courses provided toxicity is limited Patients are followed for survival
PROJECTED ACCRUAL 20 patients will be entered
OUTLINE All patients receive high-dose interleukin-2 over 24 hours followed by low-dose interleukin-2 for 4 days in the absence of toxicity Patients receive a second cycle beginning 9-13 days after completion of the first cycle with response assessed approximately 2 months after initiating therapy Patients with stable or responding disease receive a second course as above those with a continued response may receive additional courses provided toxicity is limited Patients are followed for survival
PROJECTED ACCRUAL 20 patients will be entered
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-V96-1037 | None | None | None |
| CMC-09-95-16B | None | None | None |