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| ID | Type | Description | Link |
|---|---|---|---|
| 5910 | Other Grant/Funding Number | NCI | |
| 4180 | Other Identifier | Duke IRB |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CEA peptide 1-6D | Experimental | CAP-1(6D) peptide-pulsed, matured, autologous human DC produced by the AastromReplicellâ„¢ Cell Production System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CEA peptide 1-6D | Biological | CAP-1(6D) peptide-pulsed, matured, autologous human DC produced by the AastromReplicellâ„¢ Cell Production System |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 AastromReplicellâ„¢ Cell Production System | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Immune response | The ability of the epitope pulsed DC to induce CAP-1(6D) and CMV pp65-specific T cells | 12 weeks |
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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:
HLA-A201 positive
Measurable disease*
Received at least 1 prior standard chemotherapy regimen known to have a survival benefit
Previously resected brain metastases allowed provided CT scan or MRI was performed within the past month and shows no metastasis
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Immunologic
No history of autoimmune disease, including any of the following:
No active acute or chronic infection
HIV negative
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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| Name | Affiliation | Role |
|---|---|---|
| Herbert K. Lyerly, MD | Duke Cancer Institute | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke Comprehensive Cancer Center | Durham | North Carolina | 27705 | United States |
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