Ignite Creation Date:
2024-05-05 @ 10:01 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003339
Status:
COMPLETED
Last Update Posted:
2014-05-22
First Post:
1999-11-01
Brief Title:
Vaccine Therapy With or Without Interleukin-12 in Treating Patients With Stage III or Stage IV Melanoma
Sponsor:
University of Southern California
Organization:
University of Southern California
Study Overview
Official Title:
A Randomized Phase II Trial of a Vaccine Combining Tyrosinasegp100 Peptides Emulsified With Montanide ISA 51 With and Without Interleukin-12 for Patients With Resected Stages III and IV Melanoma
Status:
COMPLETED
Status Verified Date:
2014-05
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:
RATIONALE Vaccines made from a persons cancer cells may make the body build an immune response that will kill tumor cells Interleukin-12 may kill tumor cells by stopping blood flow to the tumor and by stimulating white blood cells to kill melanoma cells
PURPOSE Randomized phase II trial to determine the effectiveness of vaccine therapy given with interleukin-12 in treating patients who have stage III or stage IV melanoma
PURPOSE Randomized phase II trial to determine the effectiveness of vaccine therapy given with interleukin-12 in treating patients who have stage III or stage IV melanoma
Detailed Description:
OBJECTIVES I Evaluate immune reactivity to tyrosinase and gp100 peptides emulsified with Montanide ISA-51 ISA-51 with or without interleukin-12 following surgical resection in HLA-A2 positive patients with stage III or IV melanoma
OUTLINE This is a randomized parallel study Patients are stratified by prior therapy immunotherapy or chemotherapy vs surgery only Patients are randomized to receive 1 of 2 treatment arms Arm I Following surgery patients receive tyrosinase and gp100 peptides emulsified with Montanide ISA-51 ISA-51 subcutaneously SQ once weekly during weeks 0 2 4 6 10 14 18 and 26 for a total of 8 vaccinations Arm II Following surgery patients receive treatment as in Arm I followed by interleukin-12 SQ once weekly during weeks 0 2 4 6 10 14 18 and 26 for a total of 8 vaccinations Patients are followed at 2-4 weeks then every 3 months for 2 years after resection then every 6 months for 3 years and then yearly if without evidence of disease
PROJECTED ACCRUAL A total of 45 patients will be accrued for this study over 2 years
OUTLINE This is a randomized parallel study Patients are stratified by prior therapy immunotherapy or chemotherapy vs surgery only Patients are randomized to receive 1 of 2 treatment arms Arm I Following surgery patients receive tyrosinase and gp100 peptides emulsified with Montanide ISA-51 ISA-51 subcutaneously SQ once weekly during weeks 0 2 4 6 10 14 18 and 26 for a total of 8 vaccinations Arm II Following surgery patients receive treatment as in Arm I followed by interleukin-12 SQ once weekly during weeks 0 2 4 6 10 14 18 and 26 for a total of 8 vaccinations Patients are followed at 2-4 weeks then every 3 months for 2 years after resection then every 6 months for 3 years and then yearly if without evidence of disease
PROJECTED ACCRUAL A total of 45 patients will be accrued for this study over 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-T97-0099 | None | None | None |
| LAC-USC-10M973 | None | None | None |
| NCI-G98-1432 | None | None | None |