A Phase 1/2 interventional study of BCG vaccine and autologous tumor cell vaccine in Colorectal Cancer, sponsored by Intracel. Completed at 2 sites in United States. Open to participants aged 21 Years to 85 Years. Per ClinicalTrials.gov, last updated 2013-05-30.
Sponsored by Intracel · Phase 1/2, Interventional, and Treatment
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.
OBJECTIVES:
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.
5,734 studies on the registry are indexed under Colorectal Neoplasms; 1,481 are open to participants now.
Browse Colorectal Neoplasms studies →Intracel is the lead sponsor of 2 studies on the registry; none are open to participants now.
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DISEASE CHARACTERISTICS:
Histologically confirmed stage II or III primary adenocarcinoma of the colon
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
The record gives a start of Mar 2001 and a completion of Aug 2004. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Jul 2004. You cannot join it, but the record below documents what was studied.
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