Vaccine Therapy in Treating Patients With Refractory Stage IV Cancer
- Conditions
- Unspecified Adult Solid Tumor, Protocol Specific
- Interventions
- Biological: CEA peptide 1-6D
- Registration Number
- NCT00057915
- Lead Sponsor
- Duke University
- Brief Summary
RATIONALE: Vaccines made from a person's 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 4
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description CEA peptide 1-6D CEA peptide 1-6D CAP-1(6D) peptide-pulsed, matured, autologous human DC produced by the AastromReplicellâ„¢ Cell Production System
- Primary Outcome Measures
Name Time Method Safety 12 months The safety and feasibility of administering one cycle of CAP-1(6D) and CMV pp65 peptide-pulsed, matured, autologous human DC produced by the AastromReplicellâ„¢ Cell Production System
- Secondary Outcome Measures
Name Time Method Immune response 12 weeks The ability of the epitope pulsed DC to induce CAP-1(6D) and CMV pp65-specific T cells
Trial Locations
- Locations (1)
Duke Comprehensive Cancer Center
🇺🇸Durham, North Carolina, United States