Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005816
Status:
COMPLETED
Last Update Posted:
2013-03-20
First Post:
2000-06-02
Brief Title:
Vaccine Therapy in Treating Patients With Stage III or Stage IV Kidney Cancer
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
Active Immunotherapy of Metastatic Renal Cell Carcinoma Using Autologous Dendritic Cells Transfected With Autologous Total Tumor RNA
Status:
COMPLETED
Status Verified Date:
2008-12
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 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 stage III or stage IV kidney cancer
PURPOSE Phase I trial to study the effectiveness of vaccine therapy in treating patients who have stage III or stage IV kidney cancer
Detailed Description:
OBJECTIVES I Determine the maximum tolerated dose of autologous dendritic cells transfected with autologous total tumor RNA in patients with stage III or IV renal cell carcinoma II Assess the toxicity and feasibility of this treatment regimen in these patients III Evaluate this regimen in terms of cellular immune response clinical response and overall survival in these patients
OUTLINE This is a dose-escalation study Patients undergo nephrectomy for tumor RNA extraction followed by leukapheresis to collect peripheral blood mononuclear cells for dendritic cell DC production Patients receive autologous DC transfected with autologous renal cell carcinoma RNA both IV and intradermally on weeks 0 2 and 4 Cohorts of 3-6 patients receive escalating doses of DC IV until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity Patients are followed every 3 months for 1 year and then every 6 months for 1 year
PROJECTED ACCRUAL A total of 18 patients will be accrued for this study over 24 months
OUTLINE This is a dose-escalation study Patients undergo nephrectomy for tumor RNA extraction followed by leukapheresis to collect peripheral blood mononuclear cells for dendritic cell DC production Patients receive autologous DC transfected with autologous renal cell carcinoma RNA both IV and intradermally on weeks 0 2 and 4 Cohorts of 3-6 patients receive escalating doses of DC IV until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity Patients are followed every 3 months for 1 year and then every 6 months for 1 year
PROJECTED ACCRUAL A total of 18 patients will be accrued for this study over 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 |
|---|---|---|---|
| 1R01CA089102-01 | NIH | NCI | httpsreporternihgovquickSearch1R01CA089102-01 |
| DUMC-1862-99-10 | None | None | None |
| DUMC-DORIS-99124 | None | None | None |
| DUMC-GCRC-839 | None | None | None |
| NCI-G00-1787 | None | None | None |
| CDR0000067820 | OTHER | None | None |