A Non-Randomized Multicenter Phase I/II Study Of Active Specific Immunotherapy In Patients With Stage II and Stage III Colon Cancer
- Determine safety and immunogenicity of adjuvant autologous tumor cell vaccine in
patients with completely resected stage II or III adenocarcinoma of the colon.
OUTLINE: This is a multicenter study. Patients are stratified according to disease stage (II
Beginning 28-35 days after total surgical resection, patients receive adjuvant autologous
tumor cell vaccine intradermally once weekly for 3 vaccinations. The first 2 vaccinations
also contain BCG. Patients with stage II disease receive a fourth vaccination 6 months after
Beginning 10-17 days after the third vaccination, patients with stage III disease receive
adjuvant leucovorin calcium IV and fluorouracil IV on days 1-5. Chemotherapy continues every
28-35 days for a total of 6 courses. These patients also receive a fourth vaccination 1
month after the completion of chemotherapy.
Patients are followed at 90 days and 6 months.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
Primary Purpose: Treatment
Michael G Hanna Jr., PhD
United States: Federal Government
|Inova Fairfax Hospital||Falls Church, Virginia 22042-3300|
|John and Dorothy Morgan Cancer Center at Lehigh Valley Hospital||Allentown, Pennsylvania 18105|