Vaccine Therapy in Treating Patients With Stage II or Stage III Colon Cancer That Has Been Removed During Surgery
|ClinicalTrials.gov Identifier: NCT00016133|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : May 30, 2013
RATIONALE: Vaccines made from a patient's white blood cells and tumor cells may make the body build an immune response to kill tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining vaccine therapy with chemotherapy may kill more tumor cells.
PURPOSE: Phase I/II trial to study the effectiveness of vaccine therapy combined with leucovorin and fluorouracil in treating patients who have undergone surgery to completely remove stage II or stage III colon cancer.
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer||Biological: BCG vaccine Biological: autologous tumor cell vaccine Drug: fluorouracil Drug: leucovorin calcium Procedure: adjuvant therapy||Phase 1 Phase 2|
- 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 vs III).
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 surgical resection.
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.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||A Non-Randomized Multicenter Phase I/II Study Of Active Specific Immunotherapy In Patients With Stage II and Stage III Colon Cancer|
|Study Start Date :||March 2001|
|Actual Study Completion Date :||August 2004|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00016133
|United States, Pennsylvania|
|John and Dorothy Morgan Cancer Center at Lehigh Valley Hospital|
|Allentown, Pennsylvania, United States, 18105-1556|
|United States, Virginia|
|Inova Fairfax Hospital|
|Fairfax, Virginia, United States, 22031|
|Study Chair:||Michael G Hanna Jr., PhD||Intracel|