Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00037037
Status:
UNKNOWN
Last Update Posted:
2013-12-18
First Post:
2002-05-13
Brief Title:
Vaccine Therapy With or Without Sargramostim in Treating Patients With High-Risk or Metastatic Melanoma
Sponsor:
Herbert Irving Comprehensive Cancer Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Study of Peptide Based Vaccine Therapy in Patients With High-Risk or Metastatic Melanoma
Status:
UNKNOWN
Status Verified Date:
2004-05
Last Known Status:
ACTIVE_NOT_RECRUITING
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 Colony-stimulating factors such as sargramostim may increase the number of immune cells found in bone marrow or peripheral blood Combining vaccine therapy with sargramostim may kill more tumor cells
PURPOSE Randomized phase I trial to study the effectiveness of vaccine therapy with or without sargramostim in treating patients who have metastatic melanoma
PURPOSE Randomized phase I trial to study the effectiveness of vaccine therapy with or without sargramostim in treating patients who have metastatic melanoma
Detailed Description:
OBJECTIVES
Compare the safety of melanoma peptide vaccine with or without sargramostim GM-CSF in patients with high-risk or metastatic melanoma
Compare changes in peptide-specific cellular and humoral immunologic profiles in patients treated with these regimens
Compare tumor response in patients treated with these regimens
OUTLINE This is a randomized open-label study Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive melanoma peptide vaccine comprising tyrosinase leader injected at 2 separate sites Melan-A ELA injected at another site NY-ESO-1a and NY-ESO-1b combined and injected at one site and MAGE-10A2 injected at another site intradermally once weekly on weeks 1-6
Arm II Patients receive vaccine as in arm I Patients also receive sargramostim GM-CSF subcutaneously daily beginning 2 days before each vaccination and continuing for 5 days
Treatment in both arms continues through week 6 in the absence of disease progression or unacceptable toxicity
Patients are followed at 2 weeks
PROJECTED ACCRUAL A total of 20 patients 10 per treatment arm will be accrued for this study within 18 months
Compare the safety of melanoma peptide vaccine with or without sargramostim GM-CSF in patients with high-risk or metastatic melanoma
Compare changes in peptide-specific cellular and humoral immunologic profiles in patients treated with these regimens
Compare tumor response in patients treated with these regimens
OUTLINE This is a randomized open-label study Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive melanoma peptide vaccine comprising tyrosinase leader injected at 2 separate sites Melan-A ELA injected at another site NY-ESO-1a and NY-ESO-1b combined and injected at one site and MAGE-10A2 injected at another site intradermally once weekly on weeks 1-6
Arm II Patients receive vaccine as in arm I Patients also receive sargramostim GM-CSF subcutaneously daily beginning 2 days before each vaccination and continuing for 5 days
Treatment in both arms continues through week 6 in the absence of disease progression or unacceptable toxicity
Patients are followed at 2 weeks
PROJECTED ACCRUAL A total of 20 patients 10 per treatment arm will be accrued for this study within 18 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 |
|---|---|---|---|
| NCI-G02-2068 | None | None | None |
| CPMC-IRB-13824 | None | None | None |
| LUDWIG-LUD00-025 | None | None | None |