Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003362
Status:
COMPLETED
Last Update Posted:
2013-06-25
First Post:
1999-11-01
Brief Title:
Vaccine Therapy Plus Immune Adjuvants in Treating Patients With Advanced Melanoma
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
Pilot Trial of Multi-Epitope Melanoma Peptide Vaccine Using GM-CSF Montanide and QS-21 as Adjuvants
Status:
COMPLETED
Status Verified Date:
2013-06
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 that are found on melanoma cells may make the body build an immune response and kill melanoma cells Combining vaccine therapy with immune adjuvants such as GM-CSF Montanide ISA-51 or QS21 may be a more effective treatment for advanced melanoma
PURPOSE Randomized phase II trial to study the effectiveness of gp 100-tyrosinase peptide vaccine with one of the immune adjuvants GM-CSF Montanide ISA-51 or QS21 in treating patients who have stage III or stage IV melanoma
PURPOSE Randomized phase II trial to study the effectiveness of gp 100-tyrosinase peptide vaccine with one of the immune adjuvants GM-CSF Montanide ISA-51 or QS21 in treating patients who have stage III or stage IV melanoma
Detailed Description:
OBJECTIVES I Evaluate the immunogenicity of gp100-tyrosinase peptide vaccine with sargramostim GM-CSF Montanide ISA-51 or QS21 as adjuvant in patients with advanced melanoma II Determine the toxicity of this multiepitope melanoma peptide vaccine in conjunction with these 3 adjuvants in these patients III Evaluate the antitumor effects of this multiepitope melanoma peptide vaccine in these patients
OUTLINE This is a randomized study Patients are stratified according to age 65 years and under vs more than 65 years and previous systemic chemotherapy yes vs no Patients are randomized to 1 of 3 treatment arms Arm I Sargramostim GM-CSF as adjuvant Patients receive 3 monthly vaccinations with gp100-tyrosinase peptide vaccine administered intradermally during weeks 1 5 and 9 For each vaccination GM-CSF is administered intradermally on days 1-10 the vaccine is administered on day 7 Arm II Montanide ISA-51 Patients receive 3 monthly vaccinations with gp100-tyrosinase peptide vaccine mixed with Montanide ISA-51 and administered subcutaneously SQ during weeks 1 5 and 9 Arm III QS21 as adjuvant Patients receive 3 monthly vaccinations with gp100-tyrosinase peptide vaccine mixed with QS21 and administered SQ during weeks 1 5 and 9 Patients with stable or responding disease may receive 3 additional monthly immunizations beginning 3-6 months following completion of 1 course of immunizations if there is evidence of T cell response against either wild type peptide Patients are followed at weeks 13 and 17
PROJECTED ACCRUAL A total of 27 patients will be accrued for this study within 18-24 months
OUTLINE This is a randomized study Patients are stratified according to age 65 years and under vs more than 65 years and previous systemic chemotherapy yes vs no Patients are randomized to 1 of 3 treatment arms Arm I Sargramostim GM-CSF as adjuvant Patients receive 3 monthly vaccinations with gp100-tyrosinase peptide vaccine administered intradermally during weeks 1 5 and 9 For each vaccination GM-CSF is administered intradermally on days 1-10 the vaccine is administered on day 7 Arm II Montanide ISA-51 Patients receive 3 monthly vaccinations with gp100-tyrosinase peptide vaccine mixed with Montanide ISA-51 and administered subcutaneously SQ during weeks 1 5 and 9 Arm III QS21 as adjuvant Patients receive 3 monthly vaccinations with gp100-tyrosinase peptide vaccine mixed with QS21 and administered SQ during weeks 1 5 and 9 Patients with stable or responding disease may receive 3 additional monthly immunizations beginning 3-6 months following completion of 1 course of immunizations if there is evidence of T cell response against either wild type peptide Patients are followed at weeks 13 and 17
PROJECTED ACCRUAL A total of 27 patients will be accrued for this study within 18-24 months
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-T97-0110 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000066345 | REGISTRY | None | None |