Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00085189
Status:
COMPLETED
Last Update Posted:
2014-05-22
First Post:
2004-06-10
Brief Title:
Vaccine Therapy in Treating Patients With Stage IIC-IV Melanoma
Sponsor:
University of Southern California
Organization:
University of Southern California
Study Overview
Official Title:
A PHASE II TRIAL OF A VACCINE COMBINING MULTIPLE CLASS I PEPTIDES WITH MONTANIDE ISA 51 OR ISA 51 VG AND CpG ADJUVANT 7909 FOR PATIENTS WITH RESECTED STAGES IICIII AND IV MELANOMA
Status:
COMPLETED
Status Verified Date:
2014-05
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 pilot phase II trial studies how well giving vaccine therapy works in treating patients with stage IIC-IV melanoma Vaccines made from melanoma peptides or antigens may help the body build an effective immune response to kill tumor cells
Detailed Description:
PRIMARY OBJECTIVES I To perform a two-cohort two-stage phase II two cohort pilot trial of a multi-peptide melanoma vaccine multi-epitope melanoma peptide vaccine with Montanide ISA 51 incomplete Freunds adjuvant or ISA 51 VG Montanide ISA 51 VG with adjuvant 7909 agatolimod sodium to define the safety and tolerability of each of the regimens and to evaluate immune reactivity to a tyrosinasegp100MAGE-3 class I peptide vaccine combined with Montanide ISA 51 or ISA 51 VG with CpG adjuvant 7909 in human leukocyte antigen HLA class I A1 A3 or A11 and B44 matched patients with surgically resected stages IIC III and IV melanoma
OUTLINE Patients are assigned to 1 of 2 treatment cohorts
COHORT I Patients receive multi-epitope peptide melanoma peptide vaccine with incomplete Freunds adjuvant and agatolimod sodium subcutaneously SC at 0 2 4 6 8 10 14 18 22 26 38 and 50 weeks and then every six months for two years for up to 16 vaccinations in the absence of disease progression or unacceptable toxicity
COHORT II Patients receive multi-epitope peptide melanoma peptide vaccine with Montanide ISA 51 VG and agatolimod sodium SC at 0 2 4 6 8 10 14 18 22 26 38 and 50 weeks and then every six months for two years for up to 16 vaccinations in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up every 6 months for 3 years and then annually thereafter
OUTLINE Patients are assigned to 1 of 2 treatment cohorts
COHORT I Patients receive multi-epitope peptide melanoma peptide vaccine with incomplete Freunds adjuvant and agatolimod sodium subcutaneously SC at 0 2 4 6 8 10 14 18 22 26 38 and 50 weeks and then every six months for two years for up to 16 vaccinations in the absence of disease progression or unacceptable toxicity
COHORT II Patients receive multi-epitope peptide melanoma peptide vaccine with Montanide ISA 51 VG and agatolimod sodium SC at 0 2 4 6 8 10 14 18 22 26 38 and 50 weeks and then every six months for two years for up to 16 vaccinations in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up every 6 months for 3 years and then annually thereafter
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-2012-02593 | REGISTRY | None | None |
| CDR0000367485 | REGISTRY | PDQ Physician Data Query | None |