Clinical trial · Interventional
Gene Therapy in Treating Patients With Colon Cancer That Has Spread to the Liver
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
NCT00012155CI-TRIAL-00011111completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Metastatic Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| NV1020 | Biological | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTKemeny 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.