Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001439
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
Brief Title:
A Phase I Study of gp100 Human Melanoma Peptide Vaccine With Incomplete Freunds Adjuvant
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Phase I Study of gp100 Human Melanoma Peptide Vaccine With Incomplete Freunds Adjuvant
Status:
COMPLETED
Status Verified Date:
1999-05
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:
This is a phase I study of melanoma tumor antigen peptide vaccines The nine amino acid peptides representing HLA-A2 restricted T cell epitope of the melanoma antigen gp100 will be administered to patients emulsified in Incomplete Freunds Adjuvant IFA The study is designed to evaluate the toxicity immunologic effects and potential therapeutic role of repeated doses of gp100 peptide vaccines administered subcutaneously
Immune reactivity to the gp100 epitope peptides will be monitored in all patients by analysis of melanoma-specific T cell precursor frequency prior to and after immunization
Immune reactivity to the gp100 epitope peptides will be monitored in all patients by analysis of melanoma-specific T cell precursor frequency prior to and after immunization
Detailed Description:
This is a phase I study of melanoma tumor antigen peptide vaccines The nine amino acid peptides representing HLA-A2 restricted T cell epitope of the melanoma antigen gp100 will be administered to patients emulsified in Incomplete Freunds Adjuvant IFA The study is designed to evaluate the toxicity immunologic effects and potential therapeutic role of repeated doses of gp100 peptide vaccines administered subcutaneously
Immune reactivity to the gp100 epitope peptides will be monitored in all patients by analysis of melanoma-specific T cell precursor frequency prior to and after immunization
Immune reactivity to the gp100 epitope peptides will be monitored in all patients by analysis of melanoma-specific T cell precursor frequency prior to and after immunization
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 |
|---|---|---|---|
| 95-C-0145 | None | None | None |