Expired Study
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New York, New York 10021


Purpose:

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.


Study summary:

OBJECTIVES: - 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.


Criteria:

DISEASE CHARACTERISTICS: - 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 PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - Karnofsky 70-100% Life expectancy: - Not specified Hematopoietic: - 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) Hepatic: - 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 Renal: - Creatinine no greater than 2.0 mg/dL Other: - 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 PRIOR CONCURRENT THERAPY: 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 Chemotherapy: - 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 Radiotherapy: - No prior radiotherapy to the liver - No concurrent radiotherapy during and for 28 days after study therapy Surgery: - At least 2 weeks since prior surgery Other: - 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


NCT ID:

NCT00012155


Primary Contact:

Study Chair
Yuman Fong, MD
Memorial Sloan-Kettering Cancer Center


Backup Contact:

N/A


Location Contact:

New York, New York 10021
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 21, 2017

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