Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005841
Status:
TERMINATED
Last Update Posted:
2014-05-22
First Post:
2000-06-02
Brief Title:
Vaccine Therapy in Treating Patients With Stage III or Stage IV Melanoma
Sponsor:
University of Southern California
Organization:
University of Southern California
Study Overview
Official Title:
A Phase I Trial of a Vaccine Combining TyrosinaseGP100Mart-1 Peptides Emulsified With Montanide ISA 51 With ProGP for Patients With Resected Stages III and IV Melanoma
Status:
TERMINATED
Status Verified Date:
2014-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
ToxicitySide Effects
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 melanoma cells may make the body build an immune response to kill tumor cells Vaccine therapy plus filgrastim combined with a specific protein may be a more effective treatment for melanoma
PURPOSE This phase I trial is studying the side effects and best dose of vaccine therapy in treating patients with stage III or stage IV melanoma that has been completely removed during surgery
PURPOSE This phase I trial is studying the side effects and best dose of vaccine therapy in treating patients with stage III or stage IV melanoma that has been completely removed during surgery
Detailed Description:
OBJECTIVES I Determine the maximum tolerated dose of filgrastim G-CSF-fetal liver tyrosine kinase-3 Flt3K fusion protein when combined with melanoma peptide vaccine comprising tyrosinase368-376 peptide gp100209-217 antigen and MART-126-35 antigen emulsified in Montanide ISA-51 in patients with completely resected stage III or IV melanoma II Determine the toxicity and safety of this regimen in these patients III Determine the immune responses to tyrosinase MART-1 and gp100 antigens in patients before during and after receiving these vaccinations
OUTLINE This is a dose escalation multicenter study of filgrastim G-CSF-fetal liver tyrosine kinase-3 Flt3K G-CSF-Flt3K fusion protein Patients receive melanoma peptide vaccine comprising tyrosinase368-376 peptide gp100209-217 antigen and MART-126-35 antigen emulsified in Montanide ISA-51 subcutaneously SQ monthly for 6 months and then at 9 and 12 months for a total of 8 vaccinations Patients receive G-CSF-Flt3K fusion protein SQ daily for 3 days before immediately after and then daily for 6 days after each vaccination Cohorts of 6-10 patients receive escalating doses of G-CSF-Flt3K fusion protein until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6-10 patients experience dose limiting toxicity Patients are followed every 3 months through year 2 after resection every 6 months for 3 years and then annually thereafter until disease progression
PROJECTED ACCRUAL A total of 30-50 patients will be accrued for this study within 12-18 months
OUTLINE This is a dose escalation multicenter study of filgrastim G-CSF-fetal liver tyrosine kinase-3 Flt3K G-CSF-Flt3K fusion protein Patients receive melanoma peptide vaccine comprising tyrosinase368-376 peptide gp100209-217 antigen and MART-126-35 antigen emulsified in Montanide ISA-51 subcutaneously SQ monthly for 6 months and then at 9 and 12 months for a total of 8 vaccinations Patients receive G-CSF-Flt3K fusion protein SQ daily for 3 days before immediately after and then daily for 6 days after each vaccination Cohorts of 6-10 patients receive escalating doses of G-CSF-Flt3K fusion protein until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6-10 patients experience dose limiting toxicity Patients are followed every 3 months through year 2 after resection every 6 months for 3 years and then annually thereafter until disease progression
PROJECTED ACCRUAL A total of 30-50 patients will be accrued for this study within 12-18 months
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-470 | None | None | None |
| LAC-USC-10M993 | None | None | None |
| LAC-USC-IRB-99B028 | None | None | None |