A Pilot Trial of a CEA/TRICOM-Based Vaccine in Combination With Combined Chemotherapy/Radiotherapy in Patients With Unresectable Stage III Non-Small Cell Lung Cancer (NSCLC)
- Determine the safety and feasibility of standard paclitaxel, carboplatin, and
radiotherapy in combination with vaccinia-CEA-TRICOM vaccine, fowlpox-CEA-TRICOM
vaccine, and recombinant fowlpox GM-CSF vaccine in patients with unresectable stage III
non-small cell lung cancer.
- Determine clinical response in patients treated with this regimen.
- Determine time to disease progression and overall median survival of patients treated
with this regimen.
- Determine immunologic response in patients treated with this regimen.
OUTLINE: This is a pilot study.
- Vaccine: Patients receive vaccinia-CEA-TRICOM vaccine subcutaneously (SC) on day 0 and
fowlpox-CEA-TRICOM (rF-CEA-TRICOM) vaccine SC on days 14, 29, 43, 57, 70, 91, and 112.
Patients also receive recombinant fowlpox GM-CSF (rF-GM-CSF) vaccine SC with each
vaccination. Patients with stable or responding disease after day 112 continue to
receive rF-CEA-TRICOM and rF-GM-CSF SC every 3 weeks in the absence of disease
progression or unacceptable toxicity.
- Radiotherapy: Patients undergo radiotherapy on days 21-25, 28-32, 35-39, 42-46, 49-53,
56-60, and 63-67.
- Chemotherapy: Concurrently with radiotherapy, patients receive paclitaxel IV over 1
hour and carboplatin IV over 30 minutes on days 21, 28, 35, 42, 49, 56, and 63.
Patients also receive paclitaxel and carboplatin on days 91 and 112 (after completion
Patients are followed annually for up to 15 years.
PROJECTED ACCRUAL: A total of 10 patients will be accrued for this study within 4-6 months.
Primary Purpose: Treatment
Philip M. Arlen, MD
National Cancer Institute (NCI)
United States: Federal Government
|Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support||Bethesda, Maryland 20892-1182|