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| Descriptive Information Fields | |||||
| Brief Title † | Monoclonal Antibody Therapy and/or Vaccine Therapy in Treating Patients With Locally Advanced or Metastatic Colorectal Cancer | ||||
| 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 | ||||
| Brief Summary | 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. |
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| Detailed Description | 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. |
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| Study Phase | Phase I, Phase II | ||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Open Label | ||||
| Primary Outcome Measure † | |||||
| Secondary Outcome Measure † | |||||
| Condition † | Colorectal Cancer | ||||
| Intervention † | Drug: BCG vaccine Drug: alum adjuvant Drug: monoclonal antibody 105AD7 anti-idiotype vaccine |
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| MEDLINE PMIDs | |||||
| Links | Clinical trial summary from the National Cancer Institute's PDQ® database ![]() |
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| Recruitment Information Fields | |||||
| Recruitment Status † | Active, not recruiting | ||||
| Enrollment † | |||||
| Start Date † | April 2000 | ||||
| Completion Date | |||||
| Eligibility Criteria † | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY: Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† | |||||
| Location Countries † | United Kingdom | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00007826 | ||||
| Organization ID | CDR0000068071 | ||||
| Secondary IDs †† | ONYVAX-SGCRO01, NCI-V00-1599 | ||||
| Study Sponsor † | Onyvax Limited at St. George's Hospital Medical School | ||||
| Collaborators †† | |||||
| Investigators † |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | February 2005 | ||||
| First Received Date † | January 6, 2001 | ||||
| Last Updated Date | July 23, 2008 | ||||