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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00072098
Recruitment Status : Terminated (limited funding)
First Posted : November 6, 2003
Last Update Posted : January 11, 2017
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Max Sung, Icahn School of Medicine at Mount Sinai

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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Metastatic Cancer Biological: adenovirus vector Biological: interleukin-12 gene Phase 1

Detailed Description:


  • 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : September 2003
Actual Primary Completion Date : January 2012
Actual Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

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: adenovirus vector
Biological: interleukin-12 gene

Primary Outcome Measures :
  1. safety measure [ Time Frame: up to day 57 ]
    adverse event reporting

  2. toxicity grading [ Time Frame: up to day 57 ]
    toxicity will assessed from grades 0 to 4 as per common toxicity criteria

Secondary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • Adult

Performance status

  • Karnofsky 70-100%

Life expectancy

  • At least 16 weeks


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


  • 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


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


  • 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


Biologic therapy

  • Not specified


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

Endocrine therapy

  • At least 2 months since prior corticosteroids


  • Not specified


  • Not specified


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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00072098

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United States, New York
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Sponsors and Collaborators
Max Sung
National Cancer Institute (NCI)
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Principal Investigator: Max W. Sung, MD Icahn School of Medicine at Mount Sinai
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Responsible Party: Max Sung, Associate Professor, Icahn School of Medicine at Mount Sinai Identifier: NCT00072098    
Other Study ID Numbers: GCO 97-0564
NIH 9911-359
First Posted: November 6, 2003    Key Record Dates
Last Update Posted: January 11, 2017
Last Verified: January 2017
Keywords provided by Max Sung, Icahn School of Medicine at Mount Sinai:
stage IV colon cancer
stage IV rectal cancer
liver metastases
recurrent rectal cancer
recurrent colon cancer
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents