Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00027534
Status:
COMPLETED
Last Update Posted:
2014-09-08
First Post:
2001-12-07
Brief Title:
Vaccine Therapy in Treating Patients With Advanced or Metastatic Cancer
Sponsor:
Michael Morse MD
Organization:
Duke University
Study Overview
Official Title:
A Phase I Study Of Active Immunotherapy With Autologous Dendritic Cells Infected With CEA-6D Expressing Fowlpox -Tricom In Patients With Advanced Or Metastatic Malignancies Expressing CEA
Status:
COMPLETED
Status Verified Date:
2014-09
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 persons white blood cells that have been treated in the laboratory 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 or metastatic cancer
PURPOSE Phase I trial to study the effectiveness of vaccine therapy in treating patients who have advanced or metastatic cancer
Detailed Description:
OBJECTIVES
Determine the safety and feasibility of active immunotherapy comprising autologous dendritic cells infected with recombinant fowlpox-CEA-TRICOM vaccine in patients with advanced or metastatic malignancies expressing CEA
Assess the CEA-specific immune response of patients treated with this regimen
Assess in a preliminary manner the clinical response rate of patients treated with this regimen
OUTLINE This is a dose-escalation study
Autologous dendritic cells ADCs are harvested and infected with fowlpox-CEA-TRICOM vaccine Patients receive the infected ADCs intradermally and subcutaneously SC followed by ADCs mixed with CMV pp65 peptide and ADCs mixed with tetanus toxoid SC and intradermally on day 1 Treatment repeats every 3 weeks for a total of 4 8 or 12 immunizations in the absence of unacceptable toxicity
Cohorts of 6 patients receive an escalating number of immunizations 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
PROJECTED ACCRUAL A total of 6-18 patients will be accrued for this study
Determine the safety and feasibility of active immunotherapy comprising autologous dendritic cells infected with recombinant fowlpox-CEA-TRICOM vaccine in patients with advanced or metastatic malignancies expressing CEA
Assess the CEA-specific immune response of patients treated with this regimen
Assess in a preliminary manner the clinical response rate of patients treated with this regimen
OUTLINE This is a dose-escalation study
Autologous dendritic cells ADCs are harvested and infected with fowlpox-CEA-TRICOM vaccine Patients receive the infected ADCs intradermally and subcutaneously SC followed by ADCs mixed with CMV pp65 peptide and ADCs mixed with tetanus toxoid SC and intradermally on day 1 Treatment repeats every 3 weeks for a total of 4 8 or 12 immunizations in the absence of unacceptable toxicity
Cohorts of 6 patients receive an escalating number of immunizations 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
PROJECTED ACCRUAL A total of 6-18 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 |
|---|---|---|---|
| CDR0000069041 | Other Identifier | Duke IRB | httpsreporternihgovquickSearch1R21CA094523 |
| 1R21CA094523 | NIH | None | None |
| 2840 | OTHER | None | None |