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Safety and Efficacy of a Genetically Engineered Herpes Simplex Virus NV1020 to Treat Colorectal Cancer Metastatic to 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.
ClinicalTrials.gov Identifier: NCT00149396
Recruitment Status : Completed
First Posted : September 8, 2005
Last Update Posted : December 16, 2008
Information provided by:

Brief Summary:

This study is an open-label study. It has two stages. Stage 1 is a dose escalation phase of the study to determine and evaluate the safety and tolerability of repeated treatments with a genetically engineered herpes simplex virus NV1020 administered locoregionally to the liver.

Stage 2 is to evaluate the dose found in Stage 1 to be "optimally tolerated". Stage 2 is to assess the efficacy of the optimally tolerated dose of NV1020 by itself and in combination with second-line chemotherapy.

Assignment to Stage 1 or Stage 2 of the study is determined by when the patient enters the study.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Liver Neoplasms Drug: NV1020 Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 27 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II, Open-Label Study (With a Sequential Dose Escalation Stage Followed by an Expansion of a Selected Dose Cohort), to Evaluate the Safety and Anti-Tumor Effects of NV1020 Administered Repeatedly Via Hepatic Artery Infusion Prior to Second-Line Chemotherapy, in Patients With Colorectal Adenocarcinoma Metastatic to the Liver
Study Start Date : July 2004
Primary Completion Date : October 2008
Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Herpes Simplex
U.S. FDA Resources

Intervention Details:
    Drug: NV1020
    NV1020 dose levels: 3x10E6, 1x10E7, and 3x10E7 plaque forming units, administered via hepatic artery infusion, over 10 minutes and repeated every 1-2 weeks for 4-8 weeks

Primary Outcome Measures :
  1. Incidence of adverse events and dose limiting adverse events [ Time Frame: Last patient out ]
  2. Clinical laboratory safety results [ Time Frame: Last patient out ]
  3. NV1020 pharmacokinetics-presence of NV1020 in body fluids/skin [ Time Frame: Last patient out ]

Secondary Outcome Measures :
  1. Tumor response after administration of NV1020 followed by a minimum of 2 cycles of chemotherapy, determined by radiological (computed tomography [CT] scan) assessment of liver size and positron emission tomography (PET) scan [ Time Frame: Last patient out ]
  2. Mean change from baseline in serum carcinoembryonic antigen (CEA) after administration of NV1020 and 2 cycles of chemotherapy [ Time Frame: Last patient out ]
  3. Pharmacodynamic effects of NV1020 (NV1020 neutralizing antibody titer assay, cytokines, CEA) [ Time Frame: Last patient out ]
  4. Time to disease progression; Survival time [ Time Frame: Withdrawal or death of last patient ]

Information from the National Library of Medicine

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

Inclusion Criteria:

  1. Ability to understand and willingness to sign a written informed consent (includes willingness to avoid physical intimacy during and for 2 weeks post NV1020 treatment)
  2. 18 years or more of age
  3. Colorectal adenocarcinoma histologically confirmed within one year prior to enrollment in the study
  4. Liver dominant metastases (CT-measurable lesions with less than 50% total liver involvement), histologically confirmed
  5. Failed conventional chemotherapy for metastatic disease
  6. Candidate for additional chemotherapy
  7. Karnofsky Performance Status 70% or greater
  8. Life expectancy greater than or equal to 4 months, based on the investigator's opinion
  9. Seropositive for herpes simplex virus-1 (HSV-1)
  10. Fecund females: negative for pregnancy test (urine or serum)
  11. Effective double-barrier contraception for a minimum of 2 months following final infusion of NV1020

Exclusion Criteria:

  1. Dominant extrahepatic disease, including cerebral metastases, significant malignant ascites or other extrahepatic metastases that are symptomatic, in critical locations or otherwise likely to confound NV1020 evaluations, in the opinion of the investigator
  2. Seronegative for HSV-1
  3. Significant active/unstable non-malignant disease or laboratory test (hematology and chemistry) results that meet any of the following:

    • White blood cell count (WBC) less than or equal to 3 x 10e3/mm3
    • Absolute neutrophil count (ANC) less than or equal to 1.5 x 10e3/mm3
    • Platelets less than or equal to 100,000/mm3
    • Hemoglobin (Hgb) less than or equal to 9.0 g/dL
    • Prothrombin time/partial thromboplastin time (PT/PTT) > upper limit of normal (ULN)
    • Serum creatinine > 2.0 mg/dL
    • AST or ALT > 2.5 times ULN or total bilirubin > 1.5 times ULN
    • Alkaline phosphatase > 2.5 times ULN
  4. Chemotherapy < 4 weeks prior to the first NV1020 infusion (mitomycin or nitrosurea < 6 weeks)
  5. Immunotherapy < 6 weeks prior to the first NV1020 infusion
  6. Radiotherapy (external or internal) to the liver
  7. Major surgery (excluding pump placement and cholecystectomy) less than or equal to 2 weeks prior to the first NV1020 infusion and the patient must be clinically stable. Pump placement and cholecystectomy less than or equal to 1 week prior to the first NV1020 infusion
  8. Female who is pregnant or nursing
  9. Patients wishing to conceive within 2 months after the last infusion of NV1020
  10. Any investigational agent administered less than or equal to 4 weeks prior to NV1020 infusion
  11. Acute HSV infection requiring systemic antiviral therapy or history of serious HSV infection (e.g., ocular, encephalitic, etc.)
  12. Active viral hepatitis (evidence for infection with hepatitis A, B or C viruses)
  13. Known infection with HIV
  14. Known hypersensitivity to any component of the NV1020 formulation
  15. History of, or current, bleeding or coagulation disorder
  16. History of significant hepatic fibrosis, cirrhosis, or hemachromatosis
  17. History of malignancy other than colorectal cancer, within 5 years prior to start of study participation, with the exception of in situ cervical or skin carcinoma
  18. Active severe infection and any other concurrent disease or medical conditions that are likely to interfere with the study, as judged by the investigator
  19. Systemic corticosteroid administration < 4 weeks prior to starting NV1020 treatment
  20. Prior treatment with NV1020 or other putative oncolytic viruses

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 ClinicalTrials.gov identifier (NCT number): NCT00149396

United States, California
University of California, San Diego
San Diego, California, United States, 92093
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, Pennsylvania
University of Pittsburgh Cancer Center
Pittsburgh, Pennsylvania, United States, 15213
United States, Tennessee
University of Vanderbilt
Nashville, Tennessee, United States, 37232
United States, Texas
Mary Crowley Medical Research Center
Dallas, Texas, United States, 75201
Sponsors and Collaborators
Study Director: Hoda Tawfik, PhD MediGene

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Alice Chen, MediGene
ClinicalTrials.gov Identifier: NCT00149396     History of Changes
Other Study ID Numbers: CT1030
First Posted: September 8, 2005    Key Record Dates
Last Update Posted: December 16, 2008
Last Verified: December 2008

Keywords provided by MediGene:
Colorectal cancer metastases to liver
Colorectal Cancer
Colorectal Carcinoma
Colorectal Tumors
Colorectal Neoplasms
Rectum Cancer
Rectum tumors
Rectum carcinoma
Colon cancer
Colon tumors
Colon carcinoma
Rectum Neoplasms
Colon Neoplasms
Liver Neoplasms
Hepatic Neoplasms
Liver Tumors
Liver cancer
Hepatic Cancer
Hepatic tumors
metastatic to the liver

Additional relevant MeSH terms:
Colorectal Neoplasms
Liver Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Liver Diseases