Vaccine Therapy in Treating Patients With Colorectal Cancer Metastatic to the Liver
NCT00033748 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 56
Last updated 2016-07-19
Summary
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.
PURPOSE: Phase II trial to study the effectiveness of vaccine therapy in treating patients who have colorectal cancer that has spread to the liver.
Conditions
Interventions
- BIOLOGICAL
-
monoclonal antibody 11D10 anti-idiotype
2 mg intradermal injection q 14 days for 4 doses, then sub Q monthly for 4 months, following a 6-12 wk rest period after curative hepatic resection
- BIOLOGICAL
-
monoclonal antibody 3H1 Alu Gel
2 mg intradermal injection q 14 days for 4 doses, then sub Q monthly for 4 months, following a 6-12 wk rest period after curative hepatic resection
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH -
Alliance for Clinical Trials in Oncology
lead OTHER
Principal Investigators
-
Mitchell C. Posner, MD · University of Chicago
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2001-12-31
- Primary Completion
- 2007-03-31
- Completion
- 2010-06-30
Countries
- United States
Study Locations
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