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Sponsored by: |
Onyvax Limited at St. George's Hospital Medical School |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00007826 |
RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Vaccines made from cancer cells may make the body build an immune response to kill colorectal tumor cells.
PURPOSE: Phase I/II trial to study the effectiveness of monoclonal antibody therapy and/or vaccine therapy in treating patients who have locally advanced or metastatic colorectal cancer.
Condition | Intervention | Phase |
---|---|---|
Colorectal Cancer |
Drug: BCG vaccine Drug: alum adjuvant Drug: monoclonal antibody 105AD7 anti-idiotype vaccine |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase I/II Trial of an Allogeneic Cell Based Vaccine and an Anti-Idiotypic Antibody Vaccine Approach for Metastatic Adenocarcinoma of the Colon or Rectum |
Study Start Date: | April 2000 |
OBJECTIVES:
OUTLINE: This is an open-label study. Patients are assigned to one of three treatment arms.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 45 patients (15 per treatment arm) will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed locally advanced or metastatic adenocarcinoma of the colon or rectum
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United Kingdom, England | |
St. George's Hospital | |
London, England, United Kingdom, SW17 0QT |
Study Chair: | Fiona J. Lofts, MD | St. George's Hospital |
Study ID Numbers: | CDR0000068071, ONYVAX-SGCRO01, NCI-V00-1599 |
Study First Received: | January 6, 2001 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00007826 |
Health Authority: | United States: Federal Government |
stage II colon cancer stage III colon cancer stage IV colon cancer stage II rectal cancer |
stage III rectal cancer stage IV rectal cancer adenocarcinoma of the colon adenocarcinoma of the rectum |
BCG Vaccine Digestive System Neoplasms Immunoglobulin Idiotypes Rectal Neoplasms Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Intestinal Neoplasms Rectal neoplasm Carcinoma |
Antibodies, Monoclonal Antibodies Aluminum sulfate Digestive System Diseases Gastrointestinal Neoplasms Adenocarcinoma Rectal cancer Colorectal Neoplasms Immunoglobulins Neoplasms, Glandular and Epithelial |
Neoplasms Neoplasms by Site Neoplasms by Histologic Type Immunologic Factors |
Physiological Effects of Drugs Adjuvants, Immunologic Pharmacologic Actions |