NCT00033748

Vaccine Therapy in Treating Patients With Colorectal Cancer Metastatic to the Liver

Sequential Phase II Study of the Anti-Idiotype Monoclonal Antibody Vaccine CeaVac and TriAb in Patients With Minimal Metastatic Colorectal Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Alliance for Clinical Trials in Oncology · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

OBJECTIVES: Primary * Determine the 2-year recurrence-free survival of patients with minimal metastatic colorectal cancer after hepatic resection when treated with adjuvant monoclonal antibody 3H1 anti-idiotype vaccine and monoclonal antibody 11D10 anti-idiotype vaccine. Secondary * Determine the toxicity of this regimen in these patients. OUTLINE: This is a multicenter study. Beginning 6-12 weeks after curative hepatic resection, patients receive monoclonal antibody 3H1 anti-idiotype vaccine and monoclonal antibody 11D10 anti-idiotype vaccine intracutaneously at separate sites on days 1, 15, 29, and 45, then subcutaneously monthly for 4 months. PROJECTED ACCRUAL: A total of 63 patients will be accrued for this study within 9 months.

Conditions

• Colorectal Cancer
• Metastatic Cancer

Interventions

Type	Name	Description
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

Timeline

• Start date: 2001-12-01
• Primary completion: 2007-03-01
• Completion: 2010-06-01
• First posted: 2003-01-27
• Last updated: 2016-07-19

Locations

75 sites across 1 country: United States