NCT00012155

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Oct 2000

Longer than P75 for phase_1 colorectal-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2000

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 3, 2001

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2002

Completed
7 months until next milestone

First Posted

Study publicly available on registry

June 9, 2003

Completed
6.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

June 26, 2013

Status Verified

November 1, 2002

Enrollment Period

2.1 years

First QC Date

March 3, 2001

Last Update Submit

June 25, 2013

Conditions

Colorectal CancerMetastatic Cancer

Keywords

stage IV colon cancerrecurrent colon canceradenocarcinoma of the colonliver metastases

Interventions

NV1020BIOLOGICAL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

Related Publications (1)

  • 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.

    RESULT

MeSH Terms

Conditions

Colorectal NeoplasmsNeoplasm MetastasisColonic Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Yuman Fong, MD

    Memorial Sloan Kettering Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 3, 2001

First Posted

June 9, 2003

Study Start

October 1, 2000

Primary Completion

November 1, 2002

Study Completion

December 1, 2009

Last Updated

June 26, 2013

Record last verified: 2002-11

Locations

US(1)