Ignite Creation Date:
2024-05-05 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00085397
Status:
UNKNOWN
Last Update Posted:
2009-02-09
First Post:
2004-06-10
Brief Title:
Vaccine Therapy in Treating Patients With Stage III or Stage IV Melanoma
Sponsor:
Dana-Farber Cancer Institute
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Randomized Phase II Study of Immunization Against Melanoma Comparing Autologous Dendritic Cells Pulsed With gp100 Peptide to Autologous Dendritic Cells Fused With Autologous Tumor Cells
Status:
UNKNOWN
Status Verified Date:
2008-04
Last Known Status:
RECRUITING
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 patients dendritic cells may make the body build an immune response to kill tumor cells It is not yet known whether combining vaccine therapy with either gp100 antigen or the patients tumor cells will cause a stronger immune response and kill more tumor cells
PURPOSE This randomized phase II trial is studying vaccine therapy and gp100 antigen to see how well they work compared to vaccine therapy and patients tumor cells in treating patients with stage III or stage IV melanoma
PURPOSE This randomized phase II trial is studying vaccine therapy and gp100 antigen to see how well they work compared to vaccine therapy and patients tumor cells in treating patients with stage III or stage IV melanoma
Detailed Description:
OBJECTIVES
Primary
Compare the tumor-specific immune response in terms of the number of gp100-specific cytotoxic T-lymphocytes T-cell production of interferon gamma or T-cell proliferation in response to in vitro exposure to gp100 and tumor lysate in patients with stage III or IV melanoma treated with autologous dendritic cells DC pulsed with gp100 antigen vs autologous DC fused with autologous tumor cells
Secondary
Compare the safety and toxicity of these regimens in these patients
Compare the therapeutic effect of these regimens in these patients
OUTLINE This is a randomized study Patients are randomized to 1 of 2 treatment arms
All patients undergo leukapheresis Peripheral blood mononuclear cells are cultured to generate dendritic cells DC
Arm I Patients undergo surgical harvesting of tumor cells for subsequent fusion Patients receive vaccination comprising DC fused with autologous tumor cells subcutaneously on day 1 Treatment repeats every 21 days for 3 courses Patients who achieve a partial PR or complete response CR may receive an additional 3 courses
Arm II Patients receive vaccination comprising DC pulsed with gp100 antigen IV on day 1 Treatment repeats every 21 days for 6 courses Patients who achieve a PR or CR may receive an additional 6 courses
In both arms patients are followed monthly for 6 months
PROJECTED ACCRUAL A total of 40 patients 20 per treatment arm will be accrued for this study
Primary
Compare the tumor-specific immune response in terms of the number of gp100-specific cytotoxic T-lymphocytes T-cell production of interferon gamma or T-cell proliferation in response to in vitro exposure to gp100 and tumor lysate in patients with stage III or IV melanoma treated with autologous dendritic cells DC pulsed with gp100 antigen vs autologous DC fused with autologous tumor cells
Secondary
Compare the safety and toxicity of these regimens in these patients
Compare the therapeutic effect of these regimens in these patients
OUTLINE This is a randomized study Patients are randomized to 1 of 2 treatment arms
All patients undergo leukapheresis Peripheral blood mononuclear cells are cultured to generate dendritic cells DC
Arm I Patients undergo surgical harvesting of tumor cells for subsequent fusion Patients receive vaccination comprising DC fused with autologous tumor cells subcutaneously on day 1 Treatment repeats every 21 days for 3 courses Patients who achieve a partial PR or complete response CR may receive an additional 3 courses
Arm II Patients receive vaccination comprising DC pulsed with gp100 antigen IV on day 1 Treatment repeats every 21 days for 6 courses Patients who achieve a PR or CR may receive an additional 6 courses
In both arms patients are followed monthly for 6 months
PROJECTED ACCRUAL A total of 40 patients 20 per treatment arm will be accrued for this study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| DFCI-03123 | None | None | None |