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

January 10, 2017 updated by: Max Sung

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

22

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10029
        • Icahn School Of Medicine At Mount Sinai

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed* colorectal adenocarcinoma metastatic to the liver

    • Solitary or multiple metastatic tumors in the liver

      • Metastatic involvement of the liver no greater than 40% of estimated liver volume NOTE: *Must be from the hepatic tumor designated for study injection
  • Metastatic liver tumors must be bidimensionally measurable by CT scan or MRI
  • At least 1 metastatic liver tumor measuring at least 2.0 cm must be visualized by ultrasound (US) and accessible for US-guided percutaneous injection
  • Extrahepatic metastases allowed
  • No prior or current ascites
  • Ineligible for hepatic resection

PATIENT CHARACTERISTICS:

Age

  • Adult

Performance status

  • Karnofsky 70-100%

Life expectancy

  • At least 16 weeks

Hematopoietic

  • Granulocyte count at least 1,500/mm^3
  • Hemoglobin at least 9.0 g/dL
  • Platelet count at least 100,000/mm^3

Hepatic

  • No clinical evidence of other severe liver disease (e.g., portosystemic encephalopathy)
  • PT no greater than 14 seconds
  • Bilirubin no greater than 2.0 times upper limit of normal (ULN)
  • Transaminases no greater than 2.5 times ULN

Renal

  • Creatinine no greater than 1.5 mg/dL OR
  • Creatinine clearance at least 45 mL/min

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective nonhormonal contraception during and for at least 2 months after study participation
  • HIV negative
  • No active infection
  • No other concurrent serious medical illness
  • No other malignancy within the past 5 years except inactive nonmelanoma skin cancer, carcinoma in situ of the cervix, or grade 1 papillary bladder cancer
  • Oriented and rational
  • Weight at least 30 kg

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas)

Endocrine therapy

  • At least 2 months since prior corticosteroids

Radiotherapy

  • Not specified

Surgery

  • Not specified

Other

  • At least 2 months since prior systemic immunosuppressive drugs
  • No concurrent immunosuppressive drugs
  • No concurrent anticoagulant therapy with heparin or warfarin

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental Group
Direct intratumoral injection of metastatic hepatic tumors using an adenoviral vector expressing the human recombinant interleukin-12 gene
Biological: interleukin-12 gene
Biological: adenovirus vector

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
safety measure
Time Frame: up to day 57
adverse event reporting
up to day 57
toxicity grading
Time Frame: up to day 57
toxicity will assessed from grades 0 to 4 as per common toxicity criteria
up to day 57

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
tumor response compared at four weeks to baseline
Time Frame: baseline and four weeks
tumor masses enumerated and measured pre-treatment and 4 weeks after treatment and changes in the tumor calculated.
baseline and four weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Max Sung

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Max W. Sung, MD, Icahn School Of Medicine At Mount Sinai

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2003

Primary Completion (Actual)

January 1, 2012

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

November 4, 2003

First Submitted That Met QC Criteria

November 5, 2003

First Posted (Estimate)

November 6, 2003

Study Record Updates

Last Update Posted (Estimate)

January 11, 2017

Last Update Submitted That Met QC Criteria

January 10, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GCO 97-0564
  • MTS-GCO-975642
  • MTS-GCO-971592
  • CDR0000335463
  • NIH 9911-359

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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