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Gene Therapy in Treating Patients With Colon Cancer That Has Spread to the Liver

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: NCT00012155
Recruitment Status : Completed
First Posted : June 9, 2003
Last Update Posted : June 26, 2013
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Gene therapy may make the body build an immune response to kill tumor cells.

PURPOSE: Phase I trial to study the safety of NV1020 in patients who have colon cancer that has spread to the liver and has not responded to previous chemotherapy.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Metastatic Cancer Biological: NV1020 Phase 1

Detailed Description:


  • Determine the safety and maximum tolerated dose of a single intrahepatic NV1020 injection in patients with hepatic metastases from colon cancer that has failed first-line chemotherapy.
  • Determine the tolerability of this drug in these patients.
  • Determine preliminarily the anti-tumor activity of this drug in these patients.
  • Assess the immunogenicity of NV1020 in these patients.

OUTLINE: This is a dose escalation study.

Patients receive a single intrahepatic arterial injection of NV1020 over 10 minutes with the aid of hepatic arteriography.

Cohorts of 3 patients receive escalating doses of NV1020 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 patients experience dose-limiting toxicity.

Patients are followed at 1, 2, and 3 months post injection. Patients may participate in a separate long term (up to 1 year) follow-up study for continued assessment and monitoring.

PROJECTED ACCRUAL: A total of 27 patients will be accrued for this study.

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Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: A Phase I, Open-Label, Dose-Escalating Study Of The Safety, Tolerability, And Anti-Tumor Activity Of A Single Intrahepatic Arterial Injection Of Genetically Engineered Herpes Simplex Virus, NV1020, In Subjects With Adenocarcinoma Of The Colon With Metastasis To The Liver
Study Start Date : October 2000
Actual Primary Completion Date : November 2002
Actual Study Completion Date : December 2009

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 confirmed adenocarcinoma of the colon

    • At least 3 metastatic hepatic lesions involving both lobes
    • No extrahepatic disease
  • Failed first-line combination chemotherapy of fluorouracil plus either leucovorin calcium or irinotecan
  • Herpes simplex virus type-1 seropositive
  • Candidate for intrahepatic arterial infusion pump placement



  • 18 and over

Performance status:

  • Karnofsky 70-100%

Life expectancy:

  • Not specified


  • WBC greater than 3,000/mm^3
  • Absolute neutrophil count greater than 1,500/mm^3
  • Platelet count greater than 100,000/mm^3
  • Hemoglobin greater than 9.0 g/dL
  • No history of any blood clotting disorder (e.g., hemophilia)


  • Transaminases no greater than 3 times upper limit of normal
  • Bilirubin no greater than 2.0 mg/dL
  • No active hepatitis
  • No history of hepatic fibrosis, cirrhosis, or hemochromatosis


  • Creatinine no greater than 2.0 mg/dL


  • Not pregnant or nursing
  • Negative pregnancy test
  • All patients must use effective barrier contraception during and for at least 6 months after study
  • HIV negative
  • No active herpes infection
  • No other active uncontrolled infection
  • No prior weight loss of more than 10 lbs within the past month
  • No history of alcohol or other substance abuse
  • No concurrent unstable and/or severe medical or psychological condition
  • No history of any other medical or psychological condition that would preclude study


Biologic therapy:

  • At least 4 weeks since prior immunotherapy (e.g., interleukin-2, interleukin -12, or interferon)
  • No prior gene transfer therapy
  • No prior therapy with cytolytic virus of any type
  • No concurrent immunotherapy during and for 28 days after study therapy
  • No concurrent vaccines during and for 28 days after study therapy


  • See Disease Characteristics
  • At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
  • No concurrent chemotherapy during and for 28 days after study therapy

Endocrine therapy:

  • No concurrent systemic steroids during and for 28 days after study therapy


  • No prior radiotherapy to the liver
  • No concurrent radiotherapy during and for 28 days after study therapy


  • At least 2 weeks since prior surgery


  • At least 30 days since prior participation in investigational study
  • No concurrent antiviral agent active against herpes simplex virus (e.g., acyclovir, valacyclovir, penciclovir, famciclovir, ganciclovir, foscarnet, or cidofovir) during and for 28 days after study therapy
  • No concurrent immunosuppressive agents (e.g., cyclosporine) during and for 28 days after study therapy
  • No other concurrent investigational or anti-cancer agents during and for 28 days after study therapy

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): NCT00012155

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United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
National Cancer Institute (NCI)
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Study Chair: Yuman Fong, MD Memorial Sloan Kettering Cancer Center
Publications of Results:
Kemeny N, Jarnagin W, Guilfoyle B, et al.: Results of a phase I, dose-escalating study of the safety, tolerability and anti-tumor activity of a single injection of a genetically engineered herpes simplex virus, nv1020, in subjects with hepatic colorectal metastases. [Abstract] Ann Oncol 16 (Suppl 2): A-480, ii283, 2005.

Layout table for additonal information Identifier: NCT00012155    
Other Study ID Numbers: MSKCC-00022
CDR0000068488 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: June 9, 2003    Key Record Dates
Last Update Posted: June 26, 2013
Last Verified: November 2002
Keywords provided by National Cancer Institute (NCI):
stage IV colon cancer
recurrent colon cancer
adenocarcinoma of the colon
liver metastases
Additional relevant MeSH terms:
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Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes