Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003222
Status:
COMPLETED
Last Update Posted:
2014-12-19
First Post:
1999-11-01
Brief Title:
Vaccine Therapy Plus Interleukin-2 in Treating Patients With Stage III or Stage IV Melanoma
Sponsor:
University of Virginia
Organization:
University of Virginia
Study Overview
Official Title:
Phase II Trial for the Evaluation of the Efficacy of Vaccination With Synthetic Melanoma Peptides Either Pulsed on Dendritic Cells or Administered With GM-CSF-in-Adjuvant Plus Administration of Sustemic IL-2 in Patients With Advanced Melanoma
Status:
COMPLETED
Status Verified Date:
2014-12
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 melanoma cells may make the body build an immune response to and kill tumor cells Colony-stimulating factors such as GM-CSF may increase the number of immune cells found in the bone marrow or peripheral blood Interleukin-2 may stimulate a persons white blood cells to kill melanoma cells Combining vaccine therapy with GM-CSF and interleukin-2 may be kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of vaccines made from melanoma cells with or without GM-CSF followed by interleukin-2 in treating patients with stage III or stage IV melanoma
PURPOSE Phase II trial to study the effectiveness of vaccines made from melanoma cells with or without GM-CSF followed by interleukin-2 in treating patients with stage III or stage IV melanoma
Detailed Description:
OBJECTIVES I Compare the effectiveness of vaccination with synthetic melanoma peptides pulsed on autologous dendritic cells versus vaccination with synthetic melanoma peptides plus sargramostim GM-CSF in decreasing tumor burden in patients with high risk melanoma pulsed autologous dendritic cell arm closed 182001 II Determine whether these regimens result in increased tumor specific immune responses as measured in vitro and in vivo III Determine whether these regimens stimulate T-cell responses in these patients
OUTLINE This is an open label study Patients are included in treatment arm II only arm I closed 182001 Arm I Patients undergo leukapheresis to collect dendritic cells Patients receive a mixture of synthetic melanoma peptides gp100 antigen tyrosinase and tetanus peptides pulsed on autologous dendritic cells IV and subcutaneously SC Arm II Patients receive a mixture of synthetic melanoma peptides gp100 antigen tyrosinase and tetanus peptides and sargramostim GM-CSF emulsified in Montanide ISA-51 SC and intradermally Patients receive vaccination during weeks 0 1 2 4 5 and 6 for a total of 6 doses and interleukin-2 SC daily on days 7-49 Patients receive 3 additional vaccinations at different sites not involved with the tumor concurrently with the first 3 vaccinations Patients are evaluated at 8 weeks 12 weeks 6 months 12 months and 24 months
PROJECTED ACCRUAL A total of 27-54 patients will be accrued for this study within 2 years
OUTLINE This is an open label study Patients are included in treatment arm II only arm I closed 182001 Arm I Patients undergo leukapheresis to collect dendritic cells Patients receive a mixture of synthetic melanoma peptides gp100 antigen tyrosinase and tetanus peptides pulsed on autologous dendritic cells IV and subcutaneously SC Arm II Patients receive a mixture of synthetic melanoma peptides gp100 antigen tyrosinase and tetanus peptides and sargramostim GM-CSF emulsified in Montanide ISA-51 SC and intradermally Patients receive vaccination during weeks 0 1 2 4 5 and 6 for a total of 6 doses and interleukin-2 SC daily on days 7-49 Patients receive 3 additional vaccinations at different sites not involved with the tumor concurrently with the first 3 vaccinations Patients are evaluated at 8 weeks 12 weeks 6 months 12 months and 24 months
PROJECTED ACCRUAL A total of 27-54 patients will be accrued for this study within 2 years
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 |
|---|---|---|---|
| IRB-HSR 7621 | None | None | None |
| NCI-G98-1389 | None | None | None |