Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006385
Status:
COMPLETED
Last Update Posted:
2011-11-08
First Post:
2000-10-04
Brief Title:
Vaccine Therapy With or Without Biological Therapy in Treating Patients With Metastatic Melanoma
Sponsor:
Eastern Cooperative Oncology Group
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Evaluation of Immunization With an HLA-A2 Multi-Epitope Peptide Vaccine Containing MART-1 NSC 672643 gp100 NSC 683472 and Tyrosinase NSC 699048 Peptides Alone or in Combination With GM-CSF IFN Alpha-2b or GM-CSF IFN Alpha-2b in Patients With Metastatic Melanoma
Status:
COMPLETED
Status Verified Date:
2002-12
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 may make the body build an immune response to kill tumor cells Biological therapies such as sargramostim and interferon alfa use different ways to stimulate the immune system and stop cancer cells from growing It is not yet known if vaccine therapy if more effective with or without biological therapy for melanoma
PURPOSE Randomized phase II trial to compare the effectiveness of vaccine therapy with or without biological therapy in treating patients who have metastatic melanoma
PURPOSE Randomized phase II trial to compare the effectiveness of vaccine therapy with or without biological therapy in treating patients who have metastatic melanoma
Detailed Description:
OBJECTIVES
Determine immune response of vaccination with melanoma associated antigens MART-127-35 gp100209-217 210M and tyrosinase368-376 370D on the number of peptide specific CD8 T-cell precursors in HLA-A2 positive patients with metastatic melanoma
Determine the influence of sargramostim GM-CSF andor interferon alfa-2b IFN-A on the immune responses of these patients and toxicity of this melanoma peptide vaccine
Determine any antitumor and anti-pigmentary response that may result from immunization against MART-1 gp100 and tyrosinase peptides and determine the relationship between such clinical observations and immune responses against lineage antigens with or without GM-CSF andor IFN-A
Compare the relapse free survival and overall survival of patients treated with melanoma peptide vaccine alone or in combination with GM-CSF andor IFN-A
OUTLINE This is a randomized multicenter study
Patients are randomized to 1 of 4 treatment arms
Arm I Patients receive multiepitope peptide MEP vaccine comprising MART-127-35 gp100209-217 210M and tyrosinase368-376 370D peptides Each peptide is separately emulsified in Montanide ISA-51 and administered subcutaneously SC for a total of 2 injections per peptide on days 1 and 15
Arm II Patients receive MEP vaccine as in arm I and sargramostim GM-CSF subcutaneously SC daily on days 1-14
Arm III Patients receive MEP vaccine as in arm I and interferon alfa-2b SC three times a week
Arm IV Patients receive MEP vaccine as in arm I GM-CSF as in arm II and interferon alfa-2b as in arm III
Treatment continues every 4 weeks for a maximum of 13 courses in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 92 patients 23 per arm will be accrued for this study within 13-16 months
Determine immune response of vaccination with melanoma associated antigens MART-127-35 gp100209-217 210M and tyrosinase368-376 370D on the number of peptide specific CD8 T-cell precursors in HLA-A2 positive patients with metastatic melanoma
Determine the influence of sargramostim GM-CSF andor interferon alfa-2b IFN-A on the immune responses of these patients and toxicity of this melanoma peptide vaccine
Determine any antitumor and anti-pigmentary response that may result from immunization against MART-1 gp100 and tyrosinase peptides and determine the relationship between such clinical observations and immune responses against lineage antigens with or without GM-CSF andor IFN-A
Compare the relapse free survival and overall survival of patients treated with melanoma peptide vaccine alone or in combination with GM-CSF andor IFN-A
OUTLINE This is a randomized multicenter study
Patients are randomized to 1 of 4 treatment arms
Arm I Patients receive multiepitope peptide MEP vaccine comprising MART-127-35 gp100209-217 210M and tyrosinase368-376 370D peptides Each peptide is separately emulsified in Montanide ISA-51 and administered subcutaneously SC for a total of 2 injections per peptide on days 1 and 15
Arm II Patients receive MEP vaccine as in arm I and sargramostim GM-CSF subcutaneously SC daily on days 1-14
Arm III Patients receive MEP vaccine as in arm I and interferon alfa-2b SC three times a week
Arm IV Patients receive MEP vaccine as in arm I GM-CSF as in arm II and interferon alfa-2b as in arm III
Treatment continues every 4 weeks for a maximum of 13 courses in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 92 patients 23 per arm will be accrued for this study within 13-16 months
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| E-1696 | None | None | None |