- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00012155
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
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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Fase
- Fase 1
Contactos y Ubicaciones
Ubicaciones de estudio
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New York
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New York, New York, Estados Unidos, 10021
- Memorial Sloan-Kettering Cancer Center
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Silla de estudio: Yuman Fong, MD, Memorial Sloan Kettering Cancer Center
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- MSKCC-00022
- CDR0000068488 (Identificador de registro: PDQ (Physician Data Query))
- MGENE-NR1-001
- NCI-G01-1920
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