Phase I Trial Of Adenoviral Vector Delivery Of The Human Interleukin-12 cDNA By Intratumoral Injection In Patients With Metastatic Colorectal Cancer To The Liver
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Colorectal Cancer
- Sponsor
- Max Sung
- Enrollment
- 22
- Locations
- 1
- Primary Endpoint
- safety measure
- Status
- Terminated
- Last Updated
- 9 years ago
Overview
Brief Summary
RATIONALE: Inserting the interleukin-12 gene into a person's cancer cells may make the body build an immune response to kill tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of interleukin-12 gene when injected into the tumors of patients with liver metastases secondary to colorectal cancer.
Detailed Description
OBJECTIVES: * Determine the toxicity and maximum tolerated dose of intratumoral adenoviral vector-delivered interleukin-12 gene in patients with liver metastases secondary to colorectal cancer . * Determine the tumor response in patients treated with this regimen. * Determine the immune response in patients treated with this regimen.
Investigators
Max Sung
Associate Professor
Icahn School of Medicine at Mount Sinai
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
safety measure
Time Frame: up to day 57
adverse event reporting
toxicity grading
Time Frame: up to day 57
toxicity will assessed from grades 0 to 4 as per common toxicity criteria
Secondary Outcomes
- tumor response compared at four weeks to baseline(baseline and four weeks)