Ignite Creation Date:
2024-05-05 @ 11:40 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00103142
Status:
COMPLETED
Last Update Posted:
2015-10-14
First Post:
2005-02-07
Brief Title:
Vaccine Therapy in Treating Patients With Liver or Lung Metastases From Colorectal Cancer
Sponsor:
Michael Morse MD
Organization:
Duke University
Study Overview
Official Title:
A Phase II Study of Active Immunotherapy With PANVAC or Autologous Cultured Dendritic Cells Infected With PANVAC After Complete Resection of Hepatic or Pulmonary Metastases of Colorectal Carcinoma
Status:
COMPLETED
Status Verified Date:
2015-10
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 gene-modified virus and a persons white blood cells may make the body build an effective immune response to kill tumor cells Biological therapies such as Granulocyte-macrophage colony-stimulating factor GM-CSF may stimulate the immune system in different ways and stop tumor cells from growing Combining different types of biological therapies may kill more tumor cells
PURPOSE This randomized phase II trial is studying giving vaccine therapy together with dendritic cells to see how well it works compared to giving vaccine therapy together with GM-CSF in treating patients with liver or lung metastases from colorectal cancer removed by surgery
PURPOSE This randomized phase II trial is studying giving vaccine therapy together with dendritic cells to see how well it works compared to giving vaccine therapy together with GM-CSF in treating patients with liver or lung metastases from colorectal cancer removed by surgery
Detailed Description:
OBJECTIVES
Primary
Compare 2-year disease-free survival of patients with completely resected hepatic or pulmonary metastases secondary to colorectal cancer treated with adjuvant vaccine therapy comprising vaccinia-Carcinoembryonic antigen CEA-mucin 1 MUC-1- Triad of costimulatory molecules TRICOM vaccine PANVAC-V and fowlpox-CEA-MUC-1-TRICOM vaccine PANVAC-F administered with autologous dendritic cells or with sargramostim GM-CSF
Secondary
Compare the rate and magnitude of immune response as determined by enzyme-linked immunosorbent spot ELISpot in patients treated with these regimens
OUTLINE This is a randomized study Patients are randomized to 1 of 2 treatment arms
Arm I Patients undergo leukapheresis to obtain leukocytes for generation of autologous dendritic cells DC Patients then receive autologous DC loaded with vaccinia-CEA-MUC-1-TRICOM PANVAC-V vaccine subcutaneously SC and intradermally ID on day 1 and autologous DC loaded with fowlpox-CEA-MUC-1-TRICOM PANVAC-F vaccine subcutaneously SC and intradermally ID on days 28 56 and 84
Arm II Patients receive PANVAC-V SC on day 1 and PANVAC-F SC on days 28 56 and 84 Patients also receive sargramostim GM-CSF SC into the same injection site once daily on days 0-3 28-31 56-59 and 84-87
After completion of study treatment patients are followed for 2 years
PROJECTED ACCRUAL A total of 72 patients 36 per treatment arm will be accrued for this study within 2 years
Primary
Compare 2-year disease-free survival of patients with completely resected hepatic or pulmonary metastases secondary to colorectal cancer treated with adjuvant vaccine therapy comprising vaccinia-Carcinoembryonic antigen CEA-mucin 1 MUC-1- Triad of costimulatory molecules TRICOM vaccine PANVAC-V and fowlpox-CEA-MUC-1-TRICOM vaccine PANVAC-F administered with autologous dendritic cells or with sargramostim GM-CSF
Secondary
Compare the rate and magnitude of immune response as determined by enzyme-linked immunosorbent spot ELISpot in patients treated with these regimens
OUTLINE This is a randomized study Patients are randomized to 1 of 2 treatment arms
Arm I Patients undergo leukapheresis to obtain leukocytes for generation of autologous dendritic cells DC Patients then receive autologous DC loaded with vaccinia-CEA-MUC-1-TRICOM PANVAC-V vaccine subcutaneously SC and intradermally ID on day 1 and autologous DC loaded with fowlpox-CEA-MUC-1-TRICOM PANVAC-F vaccine subcutaneously SC and intradermally ID on days 28 56 and 84
Arm II Patients receive PANVAC-V SC on day 1 and PANVAC-F SC on days 28 56 and 84 Patients also receive sargramostim GM-CSF SC into the same injection site once daily on days 0-3 28-31 56-59 and 84-87
After completion of study treatment patients are followed for 2 years
PROJECTED ACCRUAL A total of 72 patients 36 per treatment arm 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 |
|---|---|---|---|
| CDR000041079 | OTHER | NCI | None |
| DUMC-5883-04-6RO | OTHER | None | None |