Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005633
Status:
COMPLETED
Last Update Posted:
2013-06-19
First Post:
2000-05-02
Brief Title:
Vaccine Therapy in Treating Patients With Stage III or Stage IV Melanoma
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
Vaccination of Melanoma Patients With Tyrosinase YMD and gp100 IMD-Javelin Fusion PeptidesHSP70 Complexes A Trial Comparing the Immunogenicity of Three Doses
Status:
COMPLETED
Status Verified Date:
2013-06
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
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
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
Detailed Description:
OBJECTIVES I Determine whether active specific immunization comprising tyrosinase and gp100209-217 gp100 peptides fused with OVA BiP peptide and heat shock protein 70 HSP70 induces immunity against tyrosinase and gp100 in HLA-A2 positive patients with stage III or IV melanoma II Determine the lowest optimally immunogenic dose of tyrosinase and gp100 in these patients III Determine the tolerability of this regimen in these patients
OUTLINE This is a dose escalation study of tyrosinase and gp100209-217 antigen gp100 Patients receive vaccination comprising tyrosinase and gp100 fused with OVA BiP peptide and heat shock protein 70 HSP70 subcutaneously on weeks 0 1 2 6 and 18 for a total of 5 vaccinations in the absence of disease progression or unacceptable toxicity Cohorts of 9 patients receive escalating doses of tyrosinase and gp100 until the lowest optimally immunogenic dose is determined The lowest optimally immunogenic dose is defined as the dose at which 4 or more of 9 patients demonstrate T-cell responses
PROJECTED ACCRUAL A total of 27 patients will be accrued for this study
OUTLINE This is a dose escalation study of tyrosinase and gp100209-217 antigen gp100 Patients receive vaccination comprising tyrosinase and gp100 fused with OVA BiP peptide and heat shock protein 70 HSP70 subcutaneously on weeks 0 1 2 6 and 18 for a total of 5 vaccinations in the absence of disease progression or unacceptable toxicity Cohorts of 9 patients receive escalating doses of tyrosinase and gp100 until the lowest optimally immunogenic dose is determined The lowest optimally immunogenic dose is defined as the dose at which 4 or more of 9 patients demonstrate T-cell responses
PROJECTED ACCRUAL A total of 27 patients will be accrued for this study
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-G00-1771 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000067788 | REGISTRY | None | None |