Ignite Creation Date:
2024-05-05 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00085436
Status:
COMPLETED
Last Update Posted:
2018-06-26
First Post:
2004-06-10
Brief Title:
DC Vaccine Combined With IL-2 and IFNα-2a in Treating Patients With mRCC
Sponsor:
Dartmouth-Hitchcock Medical Center
Organization:
Dartmouth-Hitchcock Medical Center
Study Overview
Official Title:
A Phase II Study Of Autologous TumorDC Vaccine DC Vaccine Combined With Interleukin-2 IL-2 And Interferon-α-2a IFNα-2a In Patients With Metastatic Renal Cell Carcinoma RCC
Status:
COMPLETED
Status Verified Date:
2018-05
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 patients dendritic cells and tumor cells may make the body build an immune response to kill tumor cells Interleukin-2 may stimulate a persons lymphocytes to kill kidney cancer cells Interferon alfa may interfere with the growth of cancer cells Combining vaccine therapy with interleukin-2 and interferon alfa may kill more tumor cells
PURPOSE This phase II trial is studying how well giving vaccine therapy together with interleukin-2 and interferon alfa works in treating patients with metastatic renal cell carcinoma kidney cancer
PURPOSE This phase II trial is studying how well giving vaccine therapy together with interleukin-2 and interferon alfa works in treating patients with metastatic renal cell carcinoma kidney cancer
Detailed Description:
OBJECTIVES
Primary
Determine the clinical response rate in patients with metastatic renal cell carcinoma treated with autologous dendritic cells DC loaded with autologous tumor lysate DC vaccine in combination with interleukin-2 and interferon-alfa
Determine the toxicity of this regimen in these patients
Secondary
Determine within relevant immune pathways the treatment-related tumor-specific immune response in patients treated with this regimen
Correlate tumor-specific immune response with objective clinical response in patients treated with this regimen
OUTLINE
Induction therapy Patients undergo leukapheresis on day -9 Patients receive autologous dendritic cells DC loaded with autologous tumor lysate DC vaccine by intranodal injection on days 0 and 14 interleukin-2 IL-2 IV continuously on days 1-5 and 15-19 and interferon-alfa IFN-α subcutaneously SC once daily on days 1 3 5 15 17 and 19
Maintenance therapy Patients undergo leukapheresis on days 33 61 and 89 Patients receive DC vaccine by intranodal injection on days 42 70 and 98 IL-2 IV continuously on days 43-47 71-75 and 99-103 and IFN-α SC once daily on days 43 45 47 71 73 75 99 101 and 103
Patients are followed every 3 months
PROJECTED ACCRUAL A total of 18-33 patients will be accrued for this study
Primary
Determine the clinical response rate in patients with metastatic renal cell carcinoma treated with autologous dendritic cells DC loaded with autologous tumor lysate DC vaccine in combination with interleukin-2 and interferon-alfa
Determine the toxicity of this regimen in these patients
Secondary
Determine within relevant immune pathways the treatment-related tumor-specific immune response in patients treated with this regimen
Correlate tumor-specific immune response with objective clinical response in patients treated with this regimen
OUTLINE
Induction therapy Patients undergo leukapheresis on day -9 Patients receive autologous dendritic cells DC loaded with autologous tumor lysate DC vaccine by intranodal injection on days 0 and 14 interleukin-2 IL-2 IV continuously on days 1-5 and 15-19 and interferon-alfa IFN-α subcutaneously SC once daily on days 1 3 5 15 17 and 19
Maintenance therapy Patients undergo leukapheresis on days 33 61 and 89 Patients receive DC vaccine by intranodal injection on days 42 70 and 98 IL-2 IV continuously on days 43-47 71-75 and 99-103 and IFN-α SC once daily on days 43 45 47 71 73 75 99 101 and 103
Patients are followed every 3 months
PROJECTED ACCRUAL A total of 18-33 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 |
|---|---|---|---|
| DMS-16090 | OTHER | Dartmouth College | httpsreporternihgovquickSearchP30CA023108 |
| R01CA095648 | NIH | None | None |
| P30CA023108 | NIH | None | None |
| DMS-0238 | OTHER | None | None |