Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00053391
Status:
COMPLETED
Last Update Posted:
2015-05-12
First Post:
2003-01-27
Brief Title:
Vaccine Therapy in Treating Patients With Stage III or Stage IV Melanoma
Sponsor:
University Hospital Erlangen
Organization:
University Hospital Erlangen
Study Overview
Official Title:
Vaccination Of HLA-A1 AndOr -A2 Stage III or IV Melanoma Patients With Tumor Peptide - Loaded Autologous Dendritic Cells That Are Generated In The Absence Or Presence Of CD40 Ligand
Status:
COMPLETED
Status Verified Date:
2015-05
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:
RATIONALE Vaccines made from a persons white blood cells mixed with tumor proteins may make the body build an immune response to kill tumor cells
PURPOSE Phase III trial to study the effectiveness of vaccine therapy in treating patients who have stage III or stage IV melanoma
PURPOSE Phase III trial to study the effectiveness of vaccine therapy in treating patients who have stage III or stage IV melanoma
Detailed Description:
OBJECTIVES
Compare the efficacy of vaccination with autologous dendritic cells pulsed with tumor and influenza antigen peptides treated with vs without ex vivo CD40-ligand in terms of tumor-specific T-cell response in patients with HLA-A1 andor HLA-A21 positive stage III or IV melanoma
Determine the safety and tolerability of these vaccinations in these patients
Determine tumor response and recurrence rates in patients treated with these vaccinations
OUTLINE This is an open-label non-randomized study
Phase I Patients undergo leukapheresis for collection of peripheral blood mononuclear cells PBMC PBMC are cultured with sargramostim GM-CSF and interleukin-4 to generate dendritic cells DCs on day -9 DCs are pulsed separately with HLA-A1 and HLA-A21-restricted flu matrix peptides derived from melanoma-associated tumor antigens MAGE-10A2 Melan-A MAGE-3 NY-ESO-1 gp100 antigen and tyrosinase peptide Half of the DCs are treated ex vivo with CD40-ligand Patients receive the peptide-pulsed DC vaccinations subcutaneously SC on days 1 14 42 and 70 in the absence of disease progression
Patients who show tumor response at least stable disease at day 98 progress to phase II of the study
Phase II Patients undergo leukapheresis as in phase I on days 102 352 and 688 Patients receive up to 6 additional booster vaccinations SC as in phase I on days 126 184 268 356 520 and 692
Patients are followed for 10 years
PROJECTED ACCRUAL A total of 8-30 patients will be accrued for this study within 6-12 months
Compare the efficacy of vaccination with autologous dendritic cells pulsed with tumor and influenza antigen peptides treated with vs without ex vivo CD40-ligand in terms of tumor-specific T-cell response in patients with HLA-A1 andor HLA-A21 positive stage III or IV melanoma
Determine the safety and tolerability of these vaccinations in these patients
Determine tumor response and recurrence rates in patients treated with these vaccinations
OUTLINE This is an open-label non-randomized study
Phase I Patients undergo leukapheresis for collection of peripheral blood mononuclear cells PBMC PBMC are cultured with sargramostim GM-CSF and interleukin-4 to generate dendritic cells DCs on day -9 DCs are pulsed separately with HLA-A1 and HLA-A21-restricted flu matrix peptides derived from melanoma-associated tumor antigens MAGE-10A2 Melan-A MAGE-3 NY-ESO-1 gp100 antigen and tyrosinase peptide Half of the DCs are treated ex vivo with CD40-ligand Patients receive the peptide-pulsed DC vaccinations subcutaneously SC on days 1 14 42 and 70 in the absence of disease progression
Patients who show tumor response at least stable disease at day 98 progress to phase II of the study
Phase II Patients undergo leukapheresis as in phase I on days 102 352 and 688 Patients receive up to 6 additional booster vaccinations SC as in phase I on days 126 184 268 356 520 and 692
Patients are followed for 10 years
PROJECTED ACCRUAL A total of 8-30 patients will be accrued for this study within 6-12 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 |
|---|---|---|---|
| EU-20232 | None | None | None |
| ERLANGEN-1490 | None | None | None |