Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006431
Status:
UNKNOWN
Last Update Posted:
2005-06-24
First Post:
2000-11-03
Brief Title:
Active Immunotherapy Of Metastatic Renal Cell Carcinoma Using Autologous Dendritic Cells Transfected With Autologous Total Tumor RNA
Sponsor:
National Center for Research Resources NCRR
Organization:
National Center for Research Resources NCRR
Study Overview
Official Title:
None
Status:
UNKNOWN
Status Verified Date:
2001-11
Last Known Status:
ACTIVE_NOT_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:
The feasibility and dose-limiting toxicity of administering escalating doses of dendritic cells transfected with autologous renal cell carcinoma RNA DCDCRCC-RNA will be defined As a secondary endpoint the ability of DCRCC-RNA to induce tumor-specific immune responses will be evaluated Finally the anti-tumor effects measured by clinical response criteria their duration and overall survival calculated at 2-year follow-up will be determined in each patient receiving dendritic cell therapy
Background Prognosis in metastatic renal cell carcinoma is poor with a median survival of less than one year Although renal cell carcinoma has shown some response to immunotherapy the results of systemic administration of biologic response modifiers in disseminated renal cell carcinoma have been poor Growing evidence suggests that active immunotherapy particularly dendritic cells DC based vaccines may prove to be a viable and clinically effective therapeutic option for patients with advanced or metastatic renal cell carcinoma
Background Prognosis in metastatic renal cell carcinoma is poor with a median survival of less than one year Although renal cell carcinoma has shown some response to immunotherapy the results of systemic administration of biologic response modifiers in disseminated renal cell carcinoma have been poor Growing evidence suggests that active immunotherapy particularly dendritic cells DC based vaccines may prove to be a viable and clinically effective therapeutic option for patients with advanced or metastatic renal cell carcinoma
Detailed Description:
Methods This study will enroll patients with renal cell carcinoma Stage III T3 N1 M0 or Stage IV T4 N0 N1 M0 - any T N2 M0 - any T any N M1 after nephrectomy Peripheral blood mononuclear cells collected through leukapheresis are processed for DC generation Mononuclear cells are separated and cultured for 7 days in GM-CSF and IL-4 Harvested DC will be pulsed with renal tumor RNA harvested during nephrectomy An aliquot of these cells will be tested for appropriate phenotype fungal and bacterial sterility as well as for endotoxin content prior to lot release Renal tumor RNA transfected DC will be stored cryopreserved until administration
The first 3 patients will be enrolled at a low dose and monitored for dose limiting toxicities If no dose limiting toxicities are seen the next 3 patients will be enrolled at the medium dose If no dose limiting toxicities are seen in the medium dose 6 additional patients will be enrolled on the high dose and will be evaluated for dose limiting toxicities If in preparation of the vaccine insufficient RNA or dendritic cells are available to perform the required three injections at the assigned dose level or if the patient is withdrawn from the study the treatment position will remain open ie no dose fractions will be given Patients in whom only the minimum number of DCRCC-RNA can be produced to deliver one IV and one ID injection will be able to receive the vaccine even if he or she is assigned to a higher dose level but will be replaced in order to assess toxicity
Data Analysis 1 To determine the short and long term toxicities associated with administration of DCRCC-RNA in patients with metastatic RCC 2 To determine feasibility of DC vaccine generation according to the proportion of patients for whom sufficient cells are generated to provide treatment 3 To determine the cellular immune response to administration of DCRCC-RNA 4 To measure the clinical responses mediated by administration of DCRCC-RNA
The first 3 patients will be enrolled at a low dose and monitored for dose limiting toxicities If no dose limiting toxicities are seen the next 3 patients will be enrolled at the medium dose If no dose limiting toxicities are seen in the medium dose 6 additional patients will be enrolled on the high dose and will be evaluated for dose limiting toxicities If in preparation of the vaccine insufficient RNA or dendritic cells are available to perform the required three injections at the assigned dose level or if the patient is withdrawn from the study the treatment position will remain open ie no dose fractions will be given Patients in whom only the minimum number of DCRCC-RNA can be produced to deliver one IV and one ID injection will be able to receive the vaccine even if he or she is assigned to a higher dose level but will be replaced in order to assess toxicity
Data Analysis 1 To determine the short and long term toxicities associated with administration of DCRCC-RNA in patients with metastatic RCC 2 To determine feasibility of DC vaccine generation according to the proportion of patients for whom sufficient cells are generated to provide treatment 3 To determine the cellular immune response to administration of DCRCC-RNA 4 To measure the clinical responses mediated by administration of DCRCC-RNA
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 |
|---|---|---|---|
| M01RR000030 | NIH | None | httpsreporternihgovquickSearchM01RR000030 |