Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006113
Status:
TERMINATED
Last Update Posted:
2014-05-22
First Post:
2000-08-03
Brief Title:
Vaccine Therapy Followed by Biological 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 II Trial of a MART-1gp100Tyrosinase Peptide-Pulsed Dendritic Cell Vaccine Treated With CD40 LigandGamma Interferon With Subcutaneous IL-2 for Patients With Metastatic Melanoma
Status:
TERMINATED
Status Verified Date:
2014-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Lack of efficacy
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 Biological therapies such as interferon gamma and interleukin-2 use different ways to stimulate the immune system and stop cancer cells from growing Combining vaccine therapy with biological therapy may kill more tumor cells
PURPOSE This phase II trial is studying giving vaccine therapy together with interferon gamma and interleukin-2 in treating patients with stage III or stage IV melanoma
PURPOSE This phase II trial is studying giving vaccine therapy together with interferon gamma and interleukin-2 in treating patients with stage III or stage IV melanoma
Detailed Description:
OBJECTIVES
Determine the clinical response rate and immune response in HLA-A2 positive patients with stage III or IV melanoma after receiving autologous dendritic cells pulsed with melanoma antigen peptides MART-126-35 gp100209-217 and tyrosinase368-376 and treated ex vivo with CD40-ligand and interferon gamma followed by interleukin-2 in vivo
Determine the toxicities of this regimen in these patients
OUTLINE This is a multicenter study
Patients undergo leukapheresis to harvest autologous dendritic cells ADCs Melanoma peptides MART-126-35 gp100209-217 and tyrosinase368-376 are pulsed separately onto ADCs which are also treated ex vivo with CD40-ligand interferon gamma interleukin-4 sargramostim GM-CSF and Candida albicans skin test reagent Patients receive each melanoma peptide pulsed ADC vaccine separately via 3 successive 10 minute infusions on day 1 Patients then receive interleukin-2 subcutaneously every 12 hours on days 2-6 Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity
Patients are followed at 4 weeks then every 3 months for 2 years then every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 21-41 patients will be accrued for this study within 18-24 months
Determine the clinical response rate and immune response in HLA-A2 positive patients with stage III or IV melanoma after receiving autologous dendritic cells pulsed with melanoma antigen peptides MART-126-35 gp100209-217 and tyrosinase368-376 and treated ex vivo with CD40-ligand and interferon gamma followed by interleukin-2 in vivo
Determine the toxicities of this regimen in these patients
OUTLINE This is a multicenter study
Patients undergo leukapheresis to harvest autologous dendritic cells ADCs Melanoma peptides MART-126-35 gp100209-217 and tyrosinase368-376 are pulsed separately onto ADCs which are also treated ex vivo with CD40-ligand interferon gamma interleukin-4 sargramostim GM-CSF and Candida albicans skin test reagent Patients receive each melanoma peptide pulsed ADC vaccine separately via 3 successive 10 minute infusions on day 1 Patients then receive interleukin-2 subcutaneously every 12 hours on days 2-6 Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity
Patients are followed at 4 weeks then every 3 months for 2 years then every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 21-41 patients will be accrued for this study within 18-24 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-T99-0102 | None | None | None |
| LAC-USC-10M991 | None | None | None |
| NCI-G00-1837 | None | None | None |