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Survival Study Of Oncophage® vs. Observation In Patients With Kidney Cancer

6. september 2012 opdateret af: Agenus Inc.

A Multi-Center, Randomized Phase III Study of Adjuvant Oncophage® Versus Observation in Subjects With High Risk of Recurrence After Surgical Treatment for Renal Cell Carcinoma

Determine whether patients receiving adjuvant HSPPC-96 treatment after surgically resected, locally advanced renal cell carcinoma have improved recurrence-free survival as compared to subjects with no adjuvant treatment.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Primary Objective:

  • The primary objective of this study is to determine whether subjects randomized to receive adjuvant HSPPC-96 after surgical resection of locally advanced renal cell carcinoma at high risk of recurrence, have improved recurrence-free survival as compared to subjects with no adjuvant treatment.

Secondary Objective:

  • Determine whether subjects randomized to receive HSPPC-96 have improved survival as compared to subjects with no adjuvant treatment.
  • Further characterize the safety profile of HSPPC-96.

Undersøgelsestype

Interventionel

Tilmelding

650

Fase

  • Fase 3

Kontakter og lokationer

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

Studiesteder

  • Belgien
      • Kortrijk, Belgien
      • Liege, Belgien
  • Canada
      • Quebec, Canada
    • Alberta
      • Calgary, Alberta, Canada
    • British Columbia
      • Vancouver, British Columbia, Canada
      • Victoria, British Columbia, Canada
    • Ontario
      • London, Ontario, Canada
      • Toronto, Ontario, Canada
    • Quebec
      • Montreal, Quebec, Canada
  • Det Forenede Kongerige
      • Bristol, Det Forenede Kongerige
      • London, Det Forenede Kongerige
  • Forenede Stater
    • Alaska
      • Anchorage, Alaska, Forenede Stater
    • Arizona
      • Tucson, Arizona, Forenede Stater
    • California
      • Los Angeles, California, Forenede Stater
      • San Francisco, California, Forenede Stater
    • Colorado
      • Denver, Colorado, Forenede Stater
    • Connecticut
      • Farmington, Connecticut, Forenede Stater
    • Florida
      • Boca Raton, Florida, Forenede Stater
      • Miami, Florida, Forenede Stater
      • Tampa, Florida, Forenede Stater
    • Georgia
      • Atlanta, Georgia, Forenede Stater
    • Illinois
      • Chicago, Illinois, Forenede Stater
      • Maywood, Illinois, Forenede Stater
    • Iowa
      • Iowa City, Iowa, Forenede Stater
    • Kansas
      • Kansas City, Kansas, Forenede Stater
    • Louisiana
      • Gretna, Louisiana, Forenede Stater, 70056
    • Maryland
      • Baltimore, Maryland, Forenede Stater, 21287
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater
    • Minnesota
      • Rochester, Minnesota, Forenede Stater, 55905
    • Missouri
      • St. Louis, Missouri, Forenede Stater
    • New Mexico
      • Albuquerque, New Mexico, Forenede Stater
    • New York
      • Manhasset, New York, Forenede Stater
      • New York City, New York, Forenede Stater
      • Rochester, New York, Forenede Stater
    • North Carolina
      • Charlotte, North Carolina, Forenede Stater
      • Winston-Salem, North Carolina, Forenede Stater
    • Ohio
      • Cincinatti, Ohio, Forenede Stater
      • Cleveland, Ohio, Forenede Stater
      • Columbus, Ohio, Forenede Stater
    • Oregon
      • Eugene, Oregon, Forenede Stater
      • Portland, Oregon, Forenede Stater
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forenede Stater
    • Tennessee
      • Knoxville, Tennessee, Forenede Stater
      • Nashville, Tennessee, Forenede Stater
    • Texas
      • Ft. Worth, Texas, Forenede Stater
      • Houston, Texas, Forenede Stater
    • Vermont
      • South Burlington, Vermont, Forenede Stater
    • Virginia
      • Richmond, Virginia, Forenede Stater
    • Washington
      • Seattle, Washington, Forenede Stater
    • Wisconsin
      • Milwaukee, Wisconsin, Forenede Stater
  • Frankrig
      • Lille, Frankrig
      • Strasbourg, Frankrig
      • Toulouse Cedex, Frankrig
      • Villejuif Cedex, Frankrig
  • Israel
      • Haifa, Israel
      • Holon, Israel
      • Jerusalem, Israel
      • Tel-Hashomer, Israel
    • Zerifin
      • Beer-Yaacob, Zerifin, Israel
  • Norge
      • Oslo, Norge
      • Stavanger, Norge
  • Polen
      • Bialystok, Polen
      • Gdansk, Polen
      • Kielce, Polen
      • Krakow, Polen
      • Lublin, Polen
      • Szczecin, Polen
      • Warsaw, Polen
  • Spanien
      • Barcelona, Spanien
      • Madrid, Spanien
      • Valencia, Spanien
  • Sverige
      • Gothenburg, Sverige
      • Lund, Sverige
      • Umea, Sverige
      • Uppsala, Sverige
  • Østrig
      • Vienna, Østrig

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

Pre-Surgery Inclusion Criteria:

  • Primary-intact resectable renal cell cancer, without known distant metastasis and be scheduled to have surgery with curative intent;
  • Tumor size greater than or equal to 5 cm OR macroscopic nodes OR renal vein thrombus OR vena cava thrombus by radiologic evaluation
  • Performance status (Zubrod / ECOG-WHO scale)less than or equal to 1 and life expectancy of greater than three months, within 2 weeks of surgery.
  • Women of child-bearing potential must have a negative urine or serum pregnancy test within 2 weeks of surgery.
  • Signed written informed consent.

Pre-Surgery Exclusion Criteria:

  • Prior chemo-, hormonal, immuno- or radiotherapy for renal cell cancer;
  • History of primary or secondary immunodeficiency, or patients using immunosuppressive drugs, e.g. systemic corticosteroids, cyclosporin A;
  • Current malignancies at other sites or previous other cancer within the last 5 years, with the exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri or basal or squamous cell carcinoma of the skin;
  • Embolization of the renal artery prior to nephrectomy;
  • Known distant metastases;
  • Active, uncontrolled infection or other serious medical illnesses.

Eligibility Assessment:

(between 2 weeks pre- and 4 weeks post-surgery)

Prior to randomization and entry into the tumor evaluation phase, all subjects must undergo testing to confirm that they are free of distant metastatic disease, and that they meet all other criteria.

Eligibility Criteria which must be assessed and confirmed prior to randomization:

  • No evidence of metastatic or residual renal carcinoma as documented by all of the following: abdominal/pelvis CT scan; chest CT scan; and brain CT or MRI scan.
  • Provide Antigenics with greater than or equal to 7 grams of viable tumor tissue
  • Adequate bone marrow function.
  • Adequate renal and hepatic function.
  • Adequate cardiac function.
  • Signed written informed consent.
  • Patients must be willing to be followed during the course of tumor evaluation and follow-up phases.
  • Male or female patients of child producing potential must agree to use adequate contraception during the treatment/observation phase of the study.
  • Patients must not use any other investigational drug for four weeks prior to the start of the tumor evaluation phase and throughout the tumor evaluation phase of the study.

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
  • Tildeling: Randomiseret
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Samarbejdspartnere og efterforskere

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

Sponsor

Agenus Inc.

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

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. juni 2000

Primær færdiggørelse (Faktiske)

1. april 2007

Studieafslutning (Faktiske)

1. april 2007

Datoer for studieregistrering

Først indsendt

12. april 2002

Først indsendt, der opfyldte QC-kriterier

12. april 2002

Først opslået (Skøn)

15. april 2002

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

7. september 2012

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

6. september 2012

Sidst verificeret

1. september 2012

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • C-100-12 Part I

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 .

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