- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Fase
- Fase 1
Kontakter og lokationer
Studiesteder
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New York
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New York, New York, Forenede Stater, 10021
- Memorial Sloan-Kettering Cancer Center
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
Samarbejdspartnere og efterforskere
Samarbejdspartnere
Efterforskere
- Studiestol: Yuman Fong, MD, Memorial Sloan Kettering Cancer Center
Publikationer og nyttige links
Generelle publikationer
- 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.
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- MSKCC-00022
- CDR0000068488 (Registry Identifier: PDQ (Physician Data Query))
- MGENE-NR1-001
- NCI-G01-1920
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