Status:
COMPLETED
Vaccine Therapy, GM-CSF, and Interferon Alfa-2b in Treating Patients With Locally Advanced or Metastatic Cancer That Expresses Carcinoembryonic Antigen (CEA)
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Adult Solid Neoplasm
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 ...
Detailed Description
PRIMARY OBJECTIVES: I. Determine the maximum tolerated dose and recommended phase II dose of interferon alfa-2b (IFN-α-2b) when administered with recombinant vaccinia-CEA(6D)-TRICOM vaccine, recombin...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2015
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT00217373
Start Date
June 1 2005
End Date
March 1 2015
Last Update
April 20 2015
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210