Vaccine Therapy, GM-CSF, and Interferon Alfa-2b in Treating Patients With Locally Advanced or Metastatic Cancer That Expresses Carcinoembryonic Antigen (CEA)
Completed · Phase 1
Conditions studied: Adult Solid Neoplasm
In brief
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.
Key facts
- Study ID
- NCT00217373
- Run by
- National Cancer Institute (NCI)
- People needed
- 33
- Starts
- 2005-06-01
- Expected to finish
- 2015-03-01
- Last updated by the study team
- 2015-04-20
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
Where it is running
- Ohio State University Comprehensive Cancer Center — Columbus, Ohio, United States
Full record on ClinicalTrials.gov
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