A Phase 1 interventional study of CEA peptide 1-6D in Unspecified Adult Solid Tumor, Protocol Specific, sponsored by Duke University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-09-08.
Sponsored by Duke University · Phase 1, Interventional, and Treatment
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.
OBJECTIVES:
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.
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.
Duke University is the lead sponsor of 2,025 studies on the registry; 275 are open to participants now.
Of its 194 completed or terminated interventional studies of FDA-regulated products, 159 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
Histologically confirmed malignancy that is refractory to standard therapy known to have a survival benefit
Carcinoembryonic antigen (CEA)-expressing tumor, as evidenced by 1 of the following:
Measurable disease*
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Immunologic
No history of autoimmune disease, including any of the following:
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
CAP-1(6D) peptide-pulsed, matured, autologous human DC produced by the AastromReplicell™ Cell Production System
Biological: CEA peptide 1-6D
CAP-1(6D) peptide-pulsed, matured, autologous human DC produced by the AastromReplicell™ Cell Production System
Also known as: carcinoembryonic antigen peptide 1-6D
Safety
The safety and feasibility of administering one cycle of CAP-1(6D) and CMV pp65 peptide-pulsed, matured, autologous human DC produced by the AastromReplicell™ Cell Production System
Time frame: 12 months
Immune response
The ability of the epitope pulsed DC to induce CAP-1(6D) and CMV pp65-specific T cells
Time frame: 12 weeks
This study is completed, as verified in Sep 2014. You cannot join it, but the record below documents what was studied.
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Duke University