Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00056134
Status:
COMPLETED
Last Update Posted:
2018-02-19
First Post:
2003-03-06
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 With Prior Depletion of CD25-Positive Cells Using Denileukin Difitox ONTAK
Status:
COMPLETED
Status Verified Date:
2018-02
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 Biological therapies such as denileukin diftitox may be able to deliver cancer-killing substances directly to melanoma cells Combining vaccine therapy with biological therapy may kill more tumor cells
PURPOSE Phase III trial to study the effectiveness of combining vaccine therapy with denileukin diftitox in treating patients who have stage III or stage IV melanoma
PURPOSE Phase III trial to study the effectiveness of combining vaccine therapy with denileukin diftitox 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 with or without ex vivo CD40-ligand and denileukin diftitox 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 in patients treated with these vaccinations
OUTLINE
Phase I Administration of denileukin diftitox and vaccinations 1 to 4 Patients undergo leukapheresis for collection of peripheral blood mononuclear cells PMBC PBMC are processed for the generation of dendritic cells DC to be used for vaccinations DC are pulsed with HLA-A1- and HLA-A21-restricted peptides derived from melanoma-associated tumor antigens DC are pulsed with or without ex vivo treatment with CD40-ligand Patients receive denileukin diftitox IV for 3 consecutive days before the first vaccination Patients receive 4 pulsed DC vaccinations subcutaneously SC on days 1 14 42 and 70 in the absence of disease progression or unacceptable toxicity
Patients who show a tumor response at least stable disease may receive vaccination 5 and further booster vaccinations
Phase II DC are generated and pulsed as in phase I Patients receive up to 6 additional booster pulsed DC vaccinations SC on days 126 184 268 356 520 and 692 in the absence of disease progession or unacceptable toxicity
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 with or without ex vivo CD40-ligand and denileukin diftitox 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 in patients treated with these vaccinations
OUTLINE
Phase I Administration of denileukin diftitox and vaccinations 1 to 4 Patients undergo leukapheresis for collection of peripheral blood mononuclear cells PMBC PBMC are processed for the generation of dendritic cells DC to be used for vaccinations DC are pulsed with HLA-A1- and HLA-A21-restricted peptides derived from melanoma-associated tumor antigens DC are pulsed with or without ex vivo treatment with CD40-ligand Patients receive denileukin diftitox IV for 3 consecutive days before the first vaccination Patients receive 4 pulsed DC vaccinations subcutaneously SC on days 1 14 42 and 70 in the absence of disease progression or unacceptable toxicity
Patients who show a tumor response at least stable disease may receive vaccination 5 and further booster vaccinations
Phase II DC are generated and pulsed as in phase I Patients receive up to 6 additional booster pulsed DC vaccinations SC on days 126 184 268 356 520 and 692 in the absence of disease progession or unacceptable toxicity
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 |
|---|---|---|---|
| ERLANGEN-ONTAK | None | None | None |
| EU-20246 | None | None | None |