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Sponsored by: |
Intracel |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00016133 |
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 | Intervention | Phase |
---|---|---|
Colorectal Cancer |
Drug: BCG vaccine Drug: autologous tumor cell vaccine Drug: fluorouracil Drug: leucovorin calcium Procedure: adjuvant therapy |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
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 |
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.
Ages Eligible for Study: | 21 Years to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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:
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 |
Study ID Numbers: | CDR0000068597, INTRACEL-ASI-2002 |
Study First Received: | May 6, 2001 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00016133 |
Health Authority: | United States: Federal Government |
stage II colon cancer stage III colon cancer adenocarcinoma of the colon |
BCG Vaccine Digestive System Neoplasms Gastrointestinal Diseases Colonic Diseases Leucovorin Intestinal Diseases Rectal Diseases Intestinal Neoplasms |
Calcium, Dietary Digestive System Diseases Fluorouracil Gastrointestinal Neoplasms Adenocarcinoma Colonic Neoplasms Colorectal Neoplasms |
Antimetabolites Antimetabolites, Antineoplastic Vitamin B Complex Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Growth Substances Physiological Effects of Drugs |
Adjuvants, Immunologic Immunosuppressive Agents Pharmacologic Actions Neoplasms Neoplasms by Site Vitamins Therapeutic Uses Micronutrients |