Clinical trial · Interventional
Vaccine Therapy, GM-CSF, and Interferon Alfa-2b in Treating Patients With Locally Advanced or Metastatic Cancer That Expresses Carcinoembryonic Antigen (CEA)
A Phase I Study of Sequential Vaccinations With Fowlpox-CEA(6D)-Tricom (B7.1/ICAM/LFA3) and Vaccinia-CEA (6D)-Tricom, in Combination With GM-CSF and Interferon-Alfa-2B in Patients With CEA-Expressing Carcinomas
- 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)
This phase I trial is studying the side effects and best dose of interferon alfa-2b when given together with vaccine therapy and GM-CSF in treating patients with locally advanced or metastatic cancer that makes CEA. Vaccines made from a gene-modified virus may help the body build an effective immune response to kill cancer cells that make carcinoembryonic antigen (CEA). Biological therapies, such as GM-CSF, may stimulate the immune system in different ways and stop cancer cells from growing. Interferon alfa-2b may interfere with the growth of cancer cells and slow cancer growth. Giving vaccine therapy together with GM-CSF and interferon alfa-2b may kill more cancer cells that make CEA.
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 |
|---|---|---|---|
| Adult Solid Neoplasm | Adult Solid Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Recombinant Fowlpox-CEA(6D)/TRICOM Vaccine | Biological | — | UNRESOLVED |
| Recombinant Interferon Alfa-2b | Biological | — | UNRESOLVED |
| Recombinant Vaccinia-CEA(6D)-TRICOM Vaccine | Biological | — | UNRESOLVED |
| Sargramostim | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- COURSE I: Patients receive recombinant vaccinia-CEA(6D)-TRICOM vaccine SC on day 1. Patients also receive sargramostim (GM-CSF) SC on days 1-4 and IFN-α-2b\* SC on days 9, 11, and 13. COURSES II-IV: Patients receive recombinant fowlpox-CEA(6D)-TRICOM vaccine SC on day 1. Patients also receive GM-CSF as in course 1 and IFN-α-2b\* SC on days 1, 3, and 5. NOTE: \*The initial cohort of 6 patients does not receive IFN-α-2b. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. After 4 courses, patients who do not have progressive disease or unacceptable toxicity may receive recombinant fowlpox-CEA (6D)-TRICOM vaccine, GM-CSF, and IFN-α-2b every 28 days for 2 more courses and then every 3 months for up to 2 years.
- interventionNames
- Biological: Recombinant Fowlpox-CEA(6D)/TRICOM Vaccine
- Biological: Recombinant Interferon Alfa-2b
- Biological: Recombinant Vaccinia-CEA(6D)-TRICOM Vaccine
- Biological: Sargramostim
Primary outcomes (1)
- measure
- MTD of IFN-alpha-2b, defined as the dose level one level beneath that dose at which 2 or more of 6 patients showed DLT, graded according to NCI CTCAE version 4.0
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria:
* Histologically confirmed carcinoembryonic antigen (CEA)-expressing carcinoma
* Metastatic or locally advanced disease
* Tumor accessible for biopsy
* Must have received ≥ 1 prior systemic regimen for metastatic disease
* No known brain metastases
* Performance status - ECOG 0-2
* Performance status - Karnofsky 60-100%
* More than 6 months
* Absolute neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Bilirubin ≤ 2.0 times upper limit of normal (ULN)
* AST and ALT ≤ 4.0 times ULN
* Hepatitis B negative
* Hepatitis C negative
* Creatinine ≤ 1.96 mg/dL
* Creatinine clearance \> 50 mL/min
* No persistent proteinuria
* Protein \< 1,000 mg by 24-hour urine collection
* No urinary sediment abnormalities
* No symptomatic congestive heart failure
* No unstable angina pectoris
* No cardiac arrhythmia
* No clinically significant cardiomyopathy requiring treatment
* No impaired function (i.e., ejection fraction \< 50%) for patients who have not had prior vaccine and are asymptomatic
* HIV negative
* No ongoing or active infection
* No history of allergic reaction to eggs or egg products
* No history of allergy or untoward reaction to prior vaccinia vaccination (e.g., smallpox immunization) or to any of its components
* No history of or active eczema or other eczematoid skin disorders
* No atopic dermatitis
* No other acute, chronic, or exfoliative skin conditions, including any of the following:
* Burns
* Impetigo
* Varicella zoster
* Severe acne
* Other open wounds or rashes
* No immunocompromised condition
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for ≥ 3 months after completion of study treatment
* No sexual contact for 3 weeks after each vaccination treatment
* Must be willing to undergo tumor biopsy
* No psychiatric illness or social situation that would preclude study compliance
* No life-threatening illness
* No other active malignancy within the past 2 years except nonmelanoma skin cancer or superficial bladder or cervical lesions treated with surgical resection
* No other uncontrolled illness
* Must be able to avoid close household contact with the following individuals for ≥ 3 weeks after vaccinia vaccination:
* Pregnant or nursing women
* Children under 5 years of age
* Individuals who are immunodeficient or immunosuppressed by disease or therapy (including HIV infection)
* Individuals with the following conditions:
* History of or active eczema or other eczematoid skin disorders
* Atopic dermatitis
* Other acute, chronic, or exfoliative skin conditions (e.g., burns, impetigo, varicella zoster, severe acne, or other open rashes or wounds)
* No concurrent influenza vaccine
* More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
* No concurrent steroid therapy, except topical or inhaled steroids
* No concurrent steroid eye drops
* More than 4 weeks since prior radiotherapy and recovered
* More than 4 weeks since prior surgery and recovered
* No prior splenectomy
* No other concurrent investigational agentsReferences
Publications (0)
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