Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005949
Status:
COMPLETED
Last Update Posted:
2013-01-16
First Post:
2000-07-05
Brief Title:
Vaccine Plus Interleukin-2 in Treating Patients With Advanced Melanoma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Study of Melanoma Vaccine NSC 683472675756 IND 6123 and Low-Dose Subcutaneous Interleukin-2 in Advanced Melanoma
Status:
COMPLETED
Status Verified Date:
2013-01
Last Known Status:
None
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:
Phase II trial to study the effectiveness of vaccine therapy plus interleukin-2 in treating patients who have advanced melanoma Vaccines made from a persons cancer cells may make the body build an immune response to kill tumor cells Interleukin-2 may stimulate a persons white blood cells to kill cancer cells Melanoma vaccine plus interleukin-2 may kill more cancer cells
Detailed Description:
PRIMARY OBJECTIVES
I Determine clinical response rates in patients with advanced melanoma treated with gp100209-217210M melanoma vaccine and low-dose interleukin-2
II Assess response duration and progression-free intervals in these patients receiving this treatment
OUTLINE
Patients receive gp100209-217210M emulsified in Montanide ISA-51 subcutaneously SC on day 1 and interleukin-2 SC on days 1-5 and 8-13 Courses repeat every 21 days in the absence of unacceptable toxicity or disease progression Patients with a complete response CR receive 3 additional courses after achieving CR
Patients are followed every 9 weeks for 3 years or until disease recurrence
PROJECTED ACCRUAL A total of 25-50 patients will be accrued for this study within 35 years
I Determine clinical response rates in patients with advanced melanoma treated with gp100209-217210M melanoma vaccine and low-dose interleukin-2
II Assess response duration and progression-free intervals in these patients receiving this treatment
OUTLINE
Patients receive gp100209-217210M emulsified in Montanide ISA-51 subcutaneously SC on day 1 and interleukin-2 SC on days 1-5 and 8-13 Courses repeat every 21 days in the absence of unacceptable toxicity or disease progression Patients with a complete response CR receive 3 additional courses after achieving CR
Patients are followed every 9 weeks for 3 years or until disease recurrence
PROJECTED ACCRUAL A total of 25-50 patients will be accrued for this study within 35 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 |
|---|---|---|---|
| CDR0000067886 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchU10CA031946 |
| CLB-509901 | None | None | None |
| U10CA031946 | NIH | None | None |