Clinical trial · Interventional
Vaccine Therapy in Treating Patients With Refractory Stage IV Cancer
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CEA peptide 1-6D | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CEA peptide 1-6D
- description
- CAP-1(6D) peptide-pulsed, matured, autologous human DC produced by the AastromReplicell™ Cell Production System
- interventionNames
- Biological: CEA peptide 1-6D
Primary outcomes (1)
- measure
- Safety
- timeFrame
- 12 months
- description
- 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
Secondary outcomes (1)
- measure
- Immune response
- timeFrame
- 12 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed malignancy that is refractory to standard therapy known to have a survival benefit * Stage IV disease * Carcinoembryonic antigen (CEA)-expressing tumor, as evidenced by 1 of the following: * Immunohistochemistry with at least 50% of the tumor with at least moderate intensity of staining * Peripheral blood CEA greater than 2.5 mg/dL * Tumor known to be universally CEA positive (i.e., colon or rectal cancer) * HLA-A201 positive * Measurable disease\* * At least 1 unidimensionally measurable lesion at least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan NOTE: \*Histologic or cytologic confirmation is not required for measurable disease restricted to a solitary lesion * 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 * 18 and over Performance status * Karnofsky 70-100% Life expectancy * More than 6 months Hematopoietic * WBC at least 3,000/mm\^3 * Hemoglobin at least 9 g/dL (transfusions or red blood cell growth factors \[e.g., epoetin alfa\] allowed) * Platelet count at least 100,000/mm\^3 Hepatic * Bilirubin less than 2.0 mg/dL (unless patient has Gilbert's disease) * SGOT/SGPT less than 1.5 times upper limit of normal * No hepatic disease that would preclude study participation * No viral hepatitis (including chronic hepatitis) by hepatitis B surface antigen and hepatitis C serology Renal * Creatinine less than 2.5 mg/dL * No urinary tract infection Cardiovascular * No New York Heart Association class III or IV heart disease Immunologic * No history of autoimmune disease, including any of the following: * Inflammatory bowel disease * Systemic lupus erythematosus * Ankylosing spondylitis * Scleroderma * Multiple sclerosis * No active acute or chronic infection * HIV negative Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No other serious chronic or acute illness that would preclude study participation * No medical or psychological impediment that would preclude study compliance * No other malignancy within the past 5 years except nonmelanoma skin cancer, controlled carcinoma in situ of the cervix, or controlled superficial bladder cancer * No allergy to study vaccine components PRIOR CONCURRENT THERAPY: Biologic therapy * At least 4 weeks since prior immunotherapy * No other concurrent immunotherapy Chemotherapy * See Disease Characteristics * At least 4 weeks since prior chemotherapy * No concurrent chemotherapy Endocrine therapy * At least 6 weeks since prior steroid therapy (except steroids administered as premedication for chemotherapy or contrast-enhanced studies) * Concurrent hormonal therapy allowed for patients with breast cancer * No concurrent steroid therapy Radiotherapy * At least 4 weeks since prior radiotherapy * No concurrent radiotherapy Surgery * Not specified Other * Recovered from prior therapy * At least 4 weeks since prior investigational therapy * At least 4 weeks since other prior therapy * Any number of prior therapies are allowed * Concurrent bisphosphonates allowed for bone metastases * No concurrent immunosuppressive therapy (e.g., azathioprine or cyclosporine) * No other concurrent experimental therapies
References
Publications (0)
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