Interleukin-12 Gene in Treating Patients With Liver Metastases Secondary to Colorectal Cancer

Phase 1

Terminated

• Conditions: Metastatic Cancer; Colorectal Cancer
• Interventions: Biological: adenovirus vector; Biological: interleukin-12 gene

• Registration Number: NCT00072098
• Lead Sponsor: Max Sung

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.

Study Timeline

• Study Start: 2003-09
• Study First Submitted: 2003-11-04
• Study First Submitted QC: 2003-11-05
• Study First Posted: 2003-11-06
• Primary Completion: 2012-01
• Study Completion: 2012-01
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-10
• Last Update Posted: 2017-01-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental Group	interleukin-12 gene	Direct intratumoral injection of metastatic hepatic tumors using an adenoviral vector expressing the human recombinant interleukin-12 gene
Experimental Group	adenovirus vector	Direct intratumoral injection of metastatic hepatic tumors using an adenoviral vector expressing the human recombinant interleukin-12 gene

Primary Outcome Measures

Name	Time	Method
safety measure	up to day 57	adverse event reporting
toxicity grading	up to day 57	toxicity will assessed from grades 0 to 4 as per common toxicity criteria

Secondary Outcome Measures

Name	Time	Method
tumor response compared at four weeks to baseline	baseline and four weeks	tumor masses enumerated and measured pre-treatment and 4 weeks after treatment and changes in the tumor calculated.

Trial Locations

Locations (1)

Icahn School of Medicine at Mount Sinai; 🇺🇸 New York, New York, United States