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Gene Therapy in Treating Patients With Colon Cancer That Has Spread to the Liver

25. juni 2013 opdateret af: Memorial Sloan Kettering Cancer Center

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

Afsluttet

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

Interventionel

Fase

  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • New York
      • New York, New York, Forenede Stater, 10021
        • Memorial Sloan-Kettering Cancer Center

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Samarbejdspartnere

Efterforskere

  • Studiestol: Yuman Fong, MD, Memorial Sloan Kettering Cancer Center

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

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

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. oktober 2000

Primær færdiggørelse (Faktiske)

1. november 2002

Studieafslutning (Faktiske)

1. december 2009

Datoer for studieregistrering

Først indsendt

3. marts 2001

Først indsendt, der opfyldte QC-kriterier

6. juni 2003

Først opslået (Skøn)

9. juni 2003

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

26. juni 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

25. juni 2013

Sidst verificeret

1. november 2002

Mere information

Begreber relateret til denne undersøgelse

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 .

Kliniske forsøg med Kolorektal cancer

Kliniske forsøg med NV1020

Abonner