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
Status
Betingelser
Betingelser
Intervention / Behandling
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
Undersøgelsestype
Fase
Fase
- Fase 1
Kontakter og lokationer
Studiesteder
-
-
New York
-
New York, New York, Forenede Stater, 10021
- Memorial Sloan-Kettering Cancer Center
-
-
Deltagelseskriterier
Berettigelseskriterier
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
Sponsor
Sponsor
Samarbejdspartnere
Samarbejdspartnere
Efterforskere
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
Studiestart
Primær færdiggørelse (Faktiske)
Primær færdiggørelse
Studieafslutning (Faktiske)
Studieafslutning
Datoer for studieregistrering
Først indsendt
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Først opslået
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering sendt
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
Andre undersøgelses-id-numre
- MSKCC-00022
- CDR0000068488 (Registry Identifier: PDQ (Physician Data Query))
- MGENE-NR1-001
- NCI-G01-1920
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .