Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00019487
Status:
COMPLETED
Last Update Posted:
2013-06-20
First Post:
2001-07-11
Brief Title:
Vaccine Therapy With or Without Interleukin-2 in Treating Patients With Metastatic Melanoma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Treatment of Patients With Metastatic Melanoma Using Cloned Peripheral Blood Lymphocytes Sensitized In Vitro to the gp209-2M Immunodominant Peptide
Status:
COMPLETED
Status Verified Date:
2003-03
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 may make the body build an immune response and kill tumor cells
PURPOSE Phase II trial to study the effectiveness of vaccine therapy in treating patients who have metastatic melanoma that has not responded to previous therapy
PURPOSE Phase II trial to study the effectiveness of vaccine therapy in treating patients who have metastatic melanoma that has not responded to previous therapy
Detailed Description:
OBJECTIVES
Determine whether reinfused activated cells alone or in conjunction with high or subcutaneous dose interleukin-2 may result in clinical tumor regression in patients with metastatic melanoma who had previously failed therapy on protocols involving immunization against the gp100 molecule
Determine the survival of infused cells with antitumor activity in these patients
OUTLINE This is a salvage regimen
Patients undergo leukopheresis to obtain peripheral blood mononuclear cells or tumor biopsy to obtain tumor infiltrating lymphocytes TIL Cells are incubated in the presence of gp209-2M peptide and then harvested and cloned Patients receive 30-minute IV infusions of these in vitro sensitized cells Treatment repeats every 2 weeks for 2 courses An additional cohort of 8 patients receives gp209-2M peptide in Montanide ISA-51 subcutaneously in 2 different sites followed 2 days later by the adoptive transfer of cloned lymphocytes At 4 to 6 weeks after the treatment courses patients with stable or regressing disease may be retreated
Patients with disease progression after 2 courses may receive 2 additional courses of cell infusion followed by interleukin-2 IL-2 on one of two schedules One cohort of patients receives IL-2 by intravenous bolus over 15 minutes every 8 hours beginning on the day after cell infusion and continuing for up to 5 days of each treatment course Another cohort receives IL-2 by daily subcutaneous injections on days 1-12 of each course of therapy If after 12-16 patients have been treated with cloned cells alone initially and responses are inadequate subsequent patients entered into this study are randomized to receive the cell infusion followed by IL-2 on one of the two described schedules
Patients are followed at 4-6 weeks
PROJECTED ACCRUAL A total of 91 patients will be accrued for this study over 2 years
Determine whether reinfused activated cells alone or in conjunction with high or subcutaneous dose interleukin-2 may result in clinical tumor regression in patients with metastatic melanoma who had previously failed therapy on protocols involving immunization against the gp100 molecule
Determine the survival of infused cells with antitumor activity in these patients
OUTLINE This is a salvage regimen
Patients undergo leukopheresis to obtain peripheral blood mononuclear cells or tumor biopsy to obtain tumor infiltrating lymphocytes TIL Cells are incubated in the presence of gp209-2M peptide and then harvested and cloned Patients receive 30-minute IV infusions of these in vitro sensitized cells Treatment repeats every 2 weeks for 2 courses An additional cohort of 8 patients receives gp209-2M peptide in Montanide ISA-51 subcutaneously in 2 different sites followed 2 days later by the adoptive transfer of cloned lymphocytes At 4 to 6 weeks after the treatment courses patients with stable or regressing disease may be retreated
Patients with disease progression after 2 courses may receive 2 additional courses of cell infusion followed by interleukin-2 IL-2 on one of two schedules One cohort of patients receives IL-2 by intravenous bolus over 15 minutes every 8 hours beginning on the day after cell infusion and continuing for up to 5 days of each treatment course Another cohort receives IL-2 by daily subcutaneous injections on days 1-12 of each course of therapy If after 12-16 patients have been treated with cloned cells alone initially and responses are inadequate subsequent patients entered into this study are randomized to receive the cell infusion followed by IL-2 on one of the two described schedules
Patients are followed at 4-6 weeks
PROJECTED ACCRUAL A total of 91 patients will be accrued for this study over 2 years
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 |
|---|---|---|---|
| NCI-T98-0012 | None | None | None |
| NCI-98-C-0095 | None | None | None |