Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004880
Status:
COMPLETED
Last Update Posted:
2020-08-03
First Post:
2000-03-07
Brief Title:
Vaccine Therapy in Treating Patients With Advanced Kidney Cancer
Sponsor:
Jonsson Comprehensive Cancer Center
Organization:
Jonsson Comprehensive Cancer Center
Study Overview
Official Title:
A Phase I Pilot Trial of a Multi-Antigen Loaded Dendritic Cell Vaccine for the Treatment of Advanced Renal Cell Carcinoma
Status:
COMPLETED
Status Verified Date:
2012-07
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 may make the body build an immune response to kill tumor cells
PURPOSE Phase I trial to study the effectiveness of vaccine therapy in treating patients who have advanced kidney cancer
PURPOSE Phase I trial to study the effectiveness of vaccine therapy in treating patients who have advanced kidney cancer
Detailed Description:
OBJECTIVES I Evaluate the safety of multiantigen loaded dendritic cells DC vaccine in patients with advanced renal cell carcinoma II Evaluate the immunologic response to this regimen in this patient population III Evaluate the clinical response to this regimen in this patient population
OUTLINE This is a sequential cohort study All patients undergo total nephrectomy to harvest primary tumor for vaccine preparation Patients without primary tumor undergo surgical resection of the accessible metastatic site for vaccine preparation Patients are assigned to 1 of 4 treatment arms Arm I Patients receive vaccination with irradiated autologous tumor lysate TuLy intradermally ID on day 0 followed by vaccination with multiantigen liposome loaded dendritic cells DC ID on days 7 14 and 21 Arm II Patients receive vaccinations as in arm I except DC are pulsed with tumor cells Arm III Patients receive vaccination with irradiated autologous tumor lysate TuLy IV on day 0 followed by vaccination with multiantigen liposome loaded DC IV on days 7 14 and 21 Arm IV Patients receive vaccinations as in arm III except DC are treated as in arm II Patients are followed on days 28 42 70 and 112
PROJECTED ACCRUAL A total of 24 patients will be accrued for this study
OUTLINE This is a sequential cohort study All patients undergo total nephrectomy to harvest primary tumor for vaccine preparation Patients without primary tumor undergo surgical resection of the accessible metastatic site for vaccine preparation Patients are assigned to 1 of 4 treatment arms Arm I Patients receive vaccination with irradiated autologous tumor lysate TuLy intradermally ID on day 0 followed by vaccination with multiantigen liposome loaded dendritic cells DC ID on days 7 14 and 21 Arm II Patients receive vaccinations as in arm I except DC are pulsed with tumor cells Arm III Patients receive vaccination with irradiated autologous tumor lysate TuLy IV on day 0 followed by vaccination with multiantigen liposome loaded DC IV on days 7 14 and 21 Arm IV Patients receive vaccinations as in arm III except DC are treated as in arm II Patients are followed on days 28 42 70 and 112
PROJECTED ACCRUAL A total of 24 patients will be accrued for this study
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-G00-1675 | None | None | None |
| UCLA-9703025 | None | None | None |