Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00031733
Status:
COMPLETED
Last Update Posted:
2014-05-22
First Post:
2002-03-08
Brief Title:
Vaccine Therapy and Interleukin-12 With Either Alum or Sargramostim After Surgery in Treating Patients With Melanoma
Sponsor:
University of Southern California
Organization:
University of Southern California
Study Overview
Official Title:
A Phase II Randomized Trial of a Vaccine Combining TyrosinaseGP100MART-1 Peptides Emulsified With Montanide ISA 51 With Interleukin-12 With Alum or GM-CSF for Patients With Resected Stages IIBC 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 peptides may make the body build an immune response Combining vaccine therapy with interleukin-12 and either alum or sargramostim may kill more tumor cells
PURPOSE Randomized phase II trial to compare the effectiveness of combining vaccine therapy with interleukin-12 and either alum or sargramostim in treating patients who have undergone surgery for stage II stage III or stage IV melanoma
PURPOSE Randomized phase II trial to compare the effectiveness of combining vaccine therapy with interleukin-12 and either alum or sargramostim in treating patients who have undergone surgery for stage II stage III or stage IV melanoma
Detailed Description:
OBJECTIVES
Compare the immune reactivity in patients with resected stage IIB IIC III or IV melanoma vaccinated with tyrosinase gp100 and MART-1 peptides emulsified with Montanide ISA-51 with interleukin-12 and either alum adjuvant or sargramostim GM-CSF
OUTLINE This is a randomized study Patients are stratified according to disease stage cutaneous stage IIB IIC III and IV vs ocular and mucosal stage III and IV Patients are randomized to 1 of 3 treatment arms
Arm I Patients receive vaccine with tyrosinase368-376 370Dgp100209-217 210MMART-126-27 27L peptides emulsified with Montanide ISA-51 ISA-51 low-dose interleukin-12 IL-12 subcutaneously SC and alum adjuvant SC on day 1 of weeks 1 3 5 7 11 15 19 27 and 53
Arm II Patients receive peptide vaccine emulsified with ISA-51 high-dose IL-12 SC and alum adjuvant SC on day 1 of weeks 1 3 5 7 11 15 19 27 and 53
Arm III Patients receive peptide vaccine emulsified with ISA-51 on day 1 and low-dose IL-12 SC and sargramostim GM-CSF SC on days 1-5 of weeks 1 3 5 7 11 15 19 27 and 53
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 60 patients 20 per treatment arm will be accrued for this study within 3 years
Compare the immune reactivity in patients with resected stage IIB IIC III or IV melanoma vaccinated with tyrosinase gp100 and MART-1 peptides emulsified with Montanide ISA-51 with interleukin-12 and either alum adjuvant or sargramostim GM-CSF
OUTLINE This is a randomized study Patients are stratified according to disease stage cutaneous stage IIB IIC III and IV vs ocular and mucosal stage III and IV Patients are randomized to 1 of 3 treatment arms
Arm I Patients receive vaccine with tyrosinase368-376 370Dgp100209-217 210MMART-126-27 27L peptides emulsified with Montanide ISA-51 ISA-51 low-dose interleukin-12 IL-12 subcutaneously SC and alum adjuvant SC on day 1 of weeks 1 3 5 7 11 15 19 27 and 53
Arm II Patients receive peptide vaccine emulsified with ISA-51 high-dose IL-12 SC and alum adjuvant SC on day 1 of weeks 1 3 5 7 11 15 19 27 and 53
Arm III Patients receive peptide vaccine emulsified with ISA-51 on day 1 and low-dose IL-12 SC and sargramostim GM-CSF SC on days 1-5 of weeks 1 3 5 7 11 15 19 27 and 53
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 60 patients 20 per treatment arm will be accrued for this study within 3 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 |
|---|---|---|---|
| LAC-USC-10M011 | None | None | None |
| LAC-USC-IRB-013030 | None | None | None |
| NCI-5506 | None | None | None |