Clinical trial · Interventional
Vaccine Therapy in Treating Patients With Advanced or Metastatic Cancer
A Phase I Study Of Active Immunotherapy With Autologous Dendritic Cells Infected With CEA-6D Expressing Fowlpox -Tricom In Patients With Advanced Or Metastatic Malignancies Expressing CEA
- 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 that have been treated in the laboratory may make the body build an immune response to kill tumor cells. PURPOSE: Phase I trial to study the effectiveness of vaccine therapy in treating patients who have advanced or metastatic cancer.
Conditions
Conditions (9)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Gallbladder Cancer | Malignant Gallbladder Neoplasm | CURATED_EXACT | 0.92 |
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Liver Cancer | Malignant Liver Neoplasm | CURATED_EXACT | 0.92 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
| Testicular Germ Cell Tumor | Testicular Germ Cell Tumor | ONTOLOGY_EXACT |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TRICOM-CEA(6D) | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- TRICOM-CEA(6D)
- description
- Subjects receiving TRICOM-CEA(6D)
- interventionNames
- Biological: TRICOM-CEA(6D)
Primary outcomes (1)
- measure
- Safety
- timeFrame
- 12-36 weeks
- description
- The primary objective of this protocol is to determine the safety and feasibility of rF-CEA(6D)-TRICOM loaded DC in, subjects with metastatic, CEA expressing malignancies.
Secondary outcomes (1)
- measure
- Immune response
- timeFrame
- 12-36 weeks
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed advanced or metastatic malignancy expressing CEA
* Metastatic disease meeting one of the following criteria:
* Measurable or nonmeasurable
* History of metastases but no current evidence of disease, meeting one of the following criteria:
* Unresectable peritoneal or lymph node metastases that cannot be detected by imaging
* Treated or resected metastatic disease considered at high risk of recurrence (predicted 5-year disease-free survival of less than 50%)
* Must have completed treatment that rendered no evidence of disease within the past year
* CEA-expressing malignancy is defined by any of the following:
* Immunohistochemical staining (at least 50% of the tumor has at least a moderate intensity of staining)
* CEA level in peripheral blood greater than 2.5 µg/L
* Tumor known to be universally CEA positive (e.g., colon and rectal cancer)
* Received prior therapy with possible survival benefit or refused such therapy
* Prior resection of brain metastases allowed provided no metastasis by CT scan or MRI of the brain within 1 month of enrollment
* Hormone receptor status:
* Not specified
PATIENT CHARACTERISTICS:
Age
* 18 and over Sex
* Male or female Menopausal status
* Not specified Performance status
* Karnofsky 70-100% Life expectancy
* More than 6 months
Hematopoietic
* WBC at least 3,000/mm\^3
* Absolute lymphocyte count at least 1,000/mm\^3
* Platelet count at least 100,000/mm\^3
* Hemoglobin at least 9 g/dL (transfusion or epoetin alfa allowed) Hepatic
* Bilirubin less than 2.0 mg/dL
* SGOT/SGPT less than 1.5 times upper limit of normal
* No active acute or chronic viral hepatitis
* Hepatitis B surface antigen negative
* Hepatitis C negative
* No other hepatic disease that would preclude study entry
Renal
* Creatinine less than 2.5 mg/dL
* No active acute or chronic urinary tract infection
Cardiovascular
* No New York Heart Association class III or IV heart disease Immunologic
* HIV negative
* No history of autoimmune disease, including, but not limited to, the following:
* Inflammatory bowel disease
* Systemic lupus erythematosus
* Rheumatoid arthritis
* Ankylosing spondylitis
* Scleroderma
* Multiple sclerosis
* No allergy to eggs or any component of study vaccine Other
* No active acute or chronic infection
* No concurrent serious acute or chronic illness that would preclude study entry
* No other medical or psychological impediment that would preclude study entry
* No other malignancy within the past 5 years except nonmelanoma skin cancer, controlled carcinoma in situ of the cervix, or controlled superficial bladder cancer
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy
* At least 4 weeks since prior biologic therapy and recovered
* No other concurrent immunotherapy
Chemotherapy
* At least 4 weeks since prior chemotherapy and recovered
* No concurrent chemotherapy
Endocrine therapy
* At least 4 weeks since prior hormonal therapy and recovered
* At least 6 weeks since prior steroids except steroids used as premedication for chemotherapy or for contrast-enhanced studies
* No concurrent steroids
Radiotherapy
* Prior palliative radiotherapy (including systemic radiolabeled compounds) for unstable or painful bone metastases in weight-bearing bones may be allowed
* At least 4 weeks since prior radiotherapy and recovered
* No concurrent radiotherapy
Surgery
* Not specified
Other
* At least 4 weeks since any other prior therapy (including experimental therapy) and recovered
* No concurrent immunosuppressives (e.g., azathioprine or cyclosporine)References
Publications (0)
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