Adult Solid Neoplasm Clinical Trial
Official title:
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
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.
Status | Completed |
Enrollment | 33 |
Est. completion date | March 2015 |
Est. primary completion date | January 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 agents |
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Ohio State University Comprehensive Cancer Center | Columbus | Ohio |
Lead Sponsor | Collaborator |
---|---|
National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Up to 112 days | Yes | |
Secondary | Incidence of adverse events, graded according to NCI CTCAE version 4.0 | All patients will be evaluable for toxicity from the time of their first treatment with rF-CEA(6D)TRICOM and rV-CEA(6D)TRICOM. | Up to 15 years | Yes |
Secondary | Response to treatment, evaluated using the new international criteria proposed by the RECIST Committee | Each patient will be assigned one of the following categories: 1) complete response, 2) partial response, 3) stable disease, 4) progressive disease, 5) early death from malignant disease, 6) early death from toxicity, 7) early death because of other cause, or 9) unknown (not assessable, insufficient data). Patients in response categories 4-9 should be considered as failing to respond to treatment (disease progression). | Up to 15 years | No |
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