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

Phase 2

Completed

• Conditions: Metastatic Cancer; Colorectal Cancer

• Registration Number: NCT00033748
• Lead Sponsor: Alliance for Clinical Trials in Oncology

Brief 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.

Study Timeline

• Study Start: 2001-12
• Study First Submitted: 2002-04-09
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Primary Completion: 2007-03
• Study Completion: 2010-06
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-15
• Last Update Posted: 2016-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Recurrence free survival	2 years

Secondary Outcome Measures

Name	Time	Method
Toxicity	5 years

Trial Locations

Locations (75)

Northeast Alabama Regional Medical Center; 🇺🇸 Anniston, Alabama, United States

Rebecca and John Moores UCSD Cancer Center; 🇺🇸 La Jolla, California, United States

Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center; 🇺🇸 Los Angeles, California, United States

Naval Medical Center - San Diego; 🇺🇸 San Diego, California, United States

Veterans Affairs Medical Center - San Diego; 🇺🇸 San Diego, California, United States

UCSF Comprehensive Cancer Center; 🇺🇸 San Francisco, California, United States

Veterans Affairs Medical Center - San Francisco; 🇺🇸 San Francisco, California, United States

CCOP - Christiana Care Health Services; 🇺🇸 Newark, Delaware, United States

Lombardi Cancer Center at Georgetown University Medical Center; 🇺🇸 Washington, District of Columbia, United States

Walter Reed Army Medical Center; 🇺🇸 Washington, District of Columbia, United States

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