Ignite Creation Date:
2024-05-05 @ 11:32 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00071981
Status:
COMPLETED
Last Update Posted:
2023-06-28
First Post:
2003-11-04
Brief Title:
Vaccine Therapy Using Melanoma Peptides for Cytotoxic T Cells and Helper T Cells in Treating Patients With Metastatic Melanoma
Sponsor:
Eastern Cooperative Oncology Group
Organization:
Eastern Cooperative Oncology Group
Study Overview
Official Title:
A Randomized Phase II Trial of Multi-Epitope Vaccination With Melanoma Peptides For Cytotoxic T Cells And Helper T Cells For Patients With Metastatic Melanoma
Status:
COMPLETED
Status Verified Date:
2023-06
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 may make the body build an immune response to kill tumor cells
PURPOSE This randomized phase II trial is studying four different vaccines using melanoma peptides from cytotoxic T cells and helper T cells to see how well they work in treating patients with metastatic melanoma
PURPOSE This randomized phase II trial is studying four different vaccines using melanoma peptides from cytotoxic T cells and helper T cells to see how well they work in treating patients with metastatic melanoma
Detailed Description:
OBJECTIVES
Compare the cytotoxic T-cell response to each of 12 melanoma peptides restricted by Human Leukocyte Antigen HLA-A1 -A2 or -A3 in patients with metastatic melanoma vaccinated with or without these 12 melanoma peptides and with or without helper peptides
Compare the helper T-cell response to each of 6 melanoma helper peptides restricted by HLA-DR molecules in patients treated with these vaccinations
Determine whether the addition of 6 melanoma helper peptides to a vaccine containing multiple class I Major histocompatibility complex MHC-restricted peptides augments T-cell responses to the class I restricted peptides in these patients
Determine preliminarily whether booster vaccination maintains immune response in patients treated with these vaccinations
Compare the rates of clinical response and survival in patients treated with these vaccinations
Determine preliminarily whether cellular immune response correlates with clinical response and survival rates in patients treated with these vaccinations
OUTLINE This is a randomized multicenter study Patients are stratified according to HLA type HLA-A1 vs HLA-A2 vs HLA-A1 and -A2 vs HLA-A3 and planned sentinel immunized node biopsy yes vs no Patients are randomized to 1 of 4 treatment arms
Arm I Patients receive 2 injections of multi-epitope peptide vaccine comprising 12 melanoma peptides restricted by Class I MHC 12MP emulsified with sargramostim Granulocyte-macrophage colony-stimulating factor GM-CSF and Montanide ISA-51 or Montanide ISA-51 VG ISA-51 intradermally ID and subcutaneously SC on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7
Arm II Patients receive 2 injections of multi-epitope peptide vaccine comprising 12MP and 1 tetanus helper peptide emulsified with GM-CSF and ISA-51 ID and SC on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7
Arm III closed to accrual as of 51908 Patients receive 2 injections of multi-epitope peptide vaccine comprising 12MP and 6 melanoma helper peptides 6HP emulsified with GM-CSF and ISA-51 ID and SC on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7
Arm IV Patients receive 2 injections of multi-epitope peptide vaccine comprising 6HP emulsified with GM-CSF and ISA-51 ID and SC on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7
In all arms patients continue therapy in the absence of unacceptable toxicity or disease progression necessitating other urgent therapy
Patients are evaluated at 8 and 12 weeks Beginning 2-3 weeks after the week-12 evaluation patients with no evidence of disease progression may receive booster vaccinations according to their randomized treatment arm Patients receive booster vaccination ID and SC once weekly for 3 weeks Treatment repeats every 9 weeks for 1 course every 12 weeks for 2 courses and then every 24 weeks for 2 courses OR for up to 2 years whichever comes first provided the patient does not require an urgent change in therapy
After completion of study treatment patients are followed every 6 months for 2 years and then for survival for 5 years from study randomization
ACTUAL ACCRUAL A total of 175 patients were accrued for this study during March 2005 and January 2009
Compare the cytotoxic T-cell response to each of 12 melanoma peptides restricted by Human Leukocyte Antigen HLA-A1 -A2 or -A3 in patients with metastatic melanoma vaccinated with or without these 12 melanoma peptides and with or without helper peptides
Compare the helper T-cell response to each of 6 melanoma helper peptides restricted by HLA-DR molecules in patients treated with these vaccinations
Determine whether the addition of 6 melanoma helper peptides to a vaccine containing multiple class I Major histocompatibility complex MHC-restricted peptides augments T-cell responses to the class I restricted peptides in these patients
Determine preliminarily whether booster vaccination maintains immune response in patients treated with these vaccinations
Compare the rates of clinical response and survival in patients treated with these vaccinations
Determine preliminarily whether cellular immune response correlates with clinical response and survival rates in patients treated with these vaccinations
OUTLINE This is a randomized multicenter study Patients are stratified according to HLA type HLA-A1 vs HLA-A2 vs HLA-A1 and -A2 vs HLA-A3 and planned sentinel immunized node biopsy yes vs no Patients are randomized to 1 of 4 treatment arms
Arm I Patients receive 2 injections of multi-epitope peptide vaccine comprising 12 melanoma peptides restricted by Class I MHC 12MP emulsified with sargramostim Granulocyte-macrophage colony-stimulating factor GM-CSF and Montanide ISA-51 or Montanide ISA-51 VG ISA-51 intradermally ID and subcutaneously SC on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7
Arm II Patients receive 2 injections of multi-epitope peptide vaccine comprising 12MP and 1 tetanus helper peptide emulsified with GM-CSF and ISA-51 ID and SC on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7
Arm III closed to accrual as of 51908 Patients receive 2 injections of multi-epitope peptide vaccine comprising 12MP and 6 melanoma helper peptides 6HP emulsified with GM-CSF and ISA-51 ID and SC on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7
Arm IV Patients receive 2 injections of multi-epitope peptide vaccine comprising 6HP emulsified with GM-CSF and ISA-51 ID and SC on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7
In all arms patients continue therapy in the absence of unacceptable toxicity or disease progression necessitating other urgent therapy
Patients are evaluated at 8 and 12 weeks Beginning 2-3 weeks after the week-12 evaluation patients with no evidence of disease progression may receive booster vaccinations according to their randomized treatment arm Patients receive booster vaccination ID and SC once weekly for 3 weeks Treatment repeats every 9 weeks for 1 course every 12 weeks for 2 courses and then every 24 weeks for 2 courses OR for up to 2 years whichever comes first provided the patient does not require an urgent change in therapy
After completion of study treatment patients are followed every 6 months for 2 years and then for survival for 5 years from study randomization
ACTUAL ACCRUAL A total of 175 patients were accrued for this study during March 2005 and January 2009
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 |
|---|---|---|---|
| U10CA021115 | NIH | None | None |
| E1602 | OTHER | Eastern Cooperative Oncology Group ECOG | httpsreporternihgovquickSearchU10CA021115 |