Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00057915
Status:
COMPLETED
Last Update Posted:
2014-09-08
First Post:
2003-04-07
Brief Title:
Vaccine Therapy in Treating Patients With Refractory Stage IV Cancer
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
A Phase I Study of Active Immunotherapy With CAP-1 6D and CMVpp65 Peptide-Pulsed Autologous Dendritic Cells Produced in the Aastromreplicell Cell Production System in Patients With Stage IV CEA Expressing Malignancies
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 mixed with peptides may make the body build an immune response to kill cancer cells
PURPOSE This phase I trial is studying the side effects and best dose of vaccine therapy in treating patients with refractory stage IV cancer
PURPOSE This phase I trial is studying the side effects and best dose of vaccine therapy in treating patients with refractory stage IV cancer
Detailed Description:
OBJECTIVES
Determine the safety and feasibility of administering 1 or 2 courses of vaccination with carcinoembryonic antigen peptide 1-6D CAP 1-6D- and CMV pp65 peptide-pulsed autologous dendritic cells in patients with refractory stage IV CEA-expressing malignancies
Determine the ability of this regimen to induce CAP 1-6D- and CMV pp65-specific T cells in these patients
Determine the antitumor effect of this regimen in terms of progression-free survival of these patients
OUTLINE This is an open-label dose-escalation study
Patients undergo leukapheresis and collection of peripheral blood mononuclear cells from which dendritic cells DC are generated and pulsed with carcinoembryonic antigen peptide 1-6D CAP 1-6D and CMV pp65 peptide Patients are assigned to 1 of 2 vaccination cohorts
Cohort I Patients receive vaccination with CAP 1-6D-pulsed DC and CMV pp65 peptide-pulsed DC subcutaneously and intradermally every 3 weeks for a total of 4 vaccinations
Cohort II Patients receive vaccinations as in cohort I every 3 weeks for a total of 8 vaccinations
For both cohorts a safe dose of the vaccine is defined as the dose at which no more than 1 of 6 patients experiences unacceptable toxicity
Patients are followed every 3 months for 1 year
PROJECTED ACCRUAL A total of 12 patients 6 per cohort will be accrued for this study within 24 months
Determine the safety and feasibility of administering 1 or 2 courses of vaccination with carcinoembryonic antigen peptide 1-6D CAP 1-6D- and CMV pp65 peptide-pulsed autologous dendritic cells in patients with refractory stage IV CEA-expressing malignancies
Determine the ability of this regimen to induce CAP 1-6D- and CMV pp65-specific T cells in these patients
Determine the antitumor effect of this regimen in terms of progression-free survival of these patients
OUTLINE This is an open-label dose-escalation study
Patients undergo leukapheresis and collection of peripheral blood mononuclear cells from which dendritic cells DC are generated and pulsed with carcinoembryonic antigen peptide 1-6D CAP 1-6D and CMV pp65 peptide Patients are assigned to 1 of 2 vaccination cohorts
Cohort I Patients receive vaccination with CAP 1-6D-pulsed DC and CMV pp65 peptide-pulsed DC subcutaneously and intradermally every 3 weeks for a total of 4 vaccinations
Cohort II Patients receive vaccinations as in cohort I every 3 weeks for a total of 8 vaccinations
For both cohorts a safe dose of the vaccine is defined as the dose at which no more than 1 of 6 patients experiences unacceptable toxicity
Patients are followed every 3 months for 1 year
PROJECTED ACCRUAL A total of 12 patients 6 per cohort will be accrued for this study within 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 |
|---|---|---|---|
| 5910 | OTHER_GRANT | None | None |
| 4180 | OTHER | Duke IRB | None |