Safety & Efficacy of NV1020 in Colorectal Cancer Metastatic to the Liver

Completed · Phase 1/Phase 2

Conditions studied: Colorectal Cancer, Liver Neoplasms

In brief

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.

Key facts

Study ID

NCT00149396

Run by

MediGene

People needed

32

Starts

2004-07-01

Expected to finish

2008-12-01

Last updated by the study team

2018-04-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)
• 18 years or more of age
• Colorectal adenocarcinoma histologically confirmed within one year prior to enrollment in the study
• Liver dominant metastases (CT-measurable lesions with less than 50% total liver involvement), histologically confirmed
• Failed conventional chemotherapy for metastatic disease (e.g. tumors no longer responding to 5-FU/leucovorin in combination with irinotecan or oxaliplatin with or without one monoclonal antibody)
• Candidate for additional chemotherapy (and/or experimental anti-cancer therapy, if this is the only remaining treatment option)
• Karnofsky Performance Status 70% or greater
• Life expectancy greater than or equal to 4 months, based on the investigator's opinion
• Seropositive for herpes simplex virus-1 (HSV-1)
• Fecund females: negative for pregnancy test (urine or serum)
• Effective double-barrier contraception for a minimum of 2 months following final infusion of NV1020

You may not qualify if…

• 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
• Seronegative for HSV-1
• 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
• Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2.5 times ULN or total bilirubin > 1.5 times ULN
• Alkaline phosphatase > 2.5 times ULN
• Chemotherapy < 4 weeks prior to the first NV1020 infusion (mitomycin or nitrosurea < 6 weeks)
• Immunotherapy < 6 weeks prior to the first NV1020 infusion
• Radiotherapy (external or internal) to the liver
• Major surgery (excluding pump placement and cholecystectomy) ≤ 2 weeks prior to the first NV1020 infusion but the subject must be clinically stable. Pump placement and cholecystectomy ≤ 1 week prior to the first NV1020 infusion but the subject must be clinically stable
• Female who is pregnant or nursing
• Patients wishing to conceive within 2 months after the last infusion of NV1020
• Any investigational agent administered less than or equal to 4 weeks prior to NV1020 infusion
• Acute HSV infection requiring systemic antiviral therapy or history of serious HSV infection (e.g., ocular, encephalitic, etc.)
• Active viral hepatitis (evidence for infection with hepatitis A, B or C viruses)
• Known infection with HIV
• Known hypersensitivity to any component of the NV1020 formulation
• History of, or current, bleeding or coagulation disorder
• History of significant hepatic fibrosis, cirrhosis, or hemachromatosis
• 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

Where it is running

• University of California, San Diego — San Diego, California, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• University of Pittsburgh Cancer Center — Pittsburgh, Pennsylvania, United States
• University of Vanderbilt — Nashville, Tennessee, United States
• Mary Crowley Medical Research Center — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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