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ABR-217620/Naptumomab Estafenatox With Interferon-alpha (IFN-alpha) Compared to IFN-alpha Alone in Patients With Advanced Renal Cell Carcinoma

30. juni 2015 opdateret af: Active Biotech AB

A Randomized, Open-label, Multi-center, Phase II/III Study on Treatment With ABR-217620/Naptumomab Estafenatox Combined With IFN-alpha vs. IFN-alpha Alone in Patients With Advanced Renal Cell Carcinoma.

The drug ABR-217620/naptumomab estafenatox is a fusion of two proteins, one that recognizes tumor cells and one that triggers an attack on the tumor cells by activating some white blood cells belonging to the body's normal immune system. This results in an accumulation of white blood cells in the cancer that can fight the cancer. This study will compare the safety and effectiveness (assessed by tumor status and survival) of ABR-217620/naptumomab estafenatox when given with standard therapy IFN-alpha to IFN-alpha alone in patients with advanced renal cell carcinoma (RCC).

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

526

Fase

  • Fase 2
  • Fase 3

Kontakter og lokationer

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

Studiesteder

  • Bulgarien
      • Pleven, Bulgarien, 5800
        • Department of Chemotherapy, University General Hospital for Active Treatment "Georgi Stranski"
      • Plovdiv, Bulgarien, 4004
        • 1st Internal Department District Dispensary for Cancer Diseases with Inpatient Hospital
      • Sofia, Bulgarien, 1431
        • Multifile Hospital "Aleksandrovska", Urology Clinic, Department of Oncourology
      • Sofia, Bulgarien, 1527
        • Oncology Clinic, University General Hospital for Active Treatment "Tzaritza Yoanna"
      • Varna, Bulgarien, 9002
        • Urology Clinic, General Hospital for Active Treatment "St. Anna"
      • Veliko Tarnovo, Bulgarien, 5000
        • Department of Chemotherapy, Inter-district Dispensary for Cancer Diseases with Inpatient Hospital
  • Den Russiske Føderation
      • Arkhangelsk, Den Russiske Føderation
        • Arkhangelsk Regional Oncology Center
      • Chelyabinsk, Den Russiske Føderation, 454087
        • Chelyabinsk Regional Oncology Center
      • Kazan, Den Russiske Føderation, 420029
        • Republican Clinical Oncology Center
      • Kazan, Den Russiske Føderation, 420111
        • Kazan City Oncology Center
      • Moscow, Den Russiske Føderation, 115478
        • Russian Oncological Research Center n.a. N.N. Blokhin
      • Moscow, Den Russiske Føderation, 105425
        • Research Institute of Urology
      • Moscow, Den Russiske Føderation, 117997
        • Russian Research Center of Radiology
      • Obninsk, Den Russiske Føderation, 249036
        • Medical Radiology Research Center
      • Orenburg, Den Russiske Føderation, 460021
        • Orenburg Regional Clinical Oncology Center
      • St. Petersburg, Den Russiske Føderation, 191104
        • Leningrad Regional Oncological Center
      • St. Petersburg, Den Russiske Føderation, 193312
        • Municipal Aleksandrovskaya Hospital
      • St. Petersburg, Den Russiske Føderation, 194354
        • Municipal Multi-Speciality Hospital #2
      • St. Petersburg, Den Russiske Føderation, 196247
        • Municipal Hospital #26
      • St. Petersburg, Den Russiske Føderation, 197022
        • Municipal Clinical Oncology Center
      • St. Petersburg, Den Russiske Føderation, 197758
        • Central Research Institute of Roentgenology and Radiology
      • St. Petersburg, Den Russiske Føderation, 197758
        • Research Institute of Oncology n.a. Professor N.N. Petrov
      • St. Petersburg, Den Russiske Føderation, 198205
        • Municipal Hospital #15
      • Stavropol, Den Russiske Føderation, 355047
        • Stavropol Territorial Clinical Oncology Center
      • Yaroslavl, Den Russiske Føderation, 150054
        • Regional Clinical Oncology Hospital
  • Det Forenede Kongerige
      • Cambridge, Det Forenede Kongerige, CB2 0QQ
        • Addenbrooke's Hospital, Cambridge Clinical Trials Centre
      • Derby, Det Forenede Kongerige, DE1 2QY
        • Derby Hospital NHS Trust
      • Glasgow, Det Forenede Kongerige, G12 0YN
        • The Beatson West of Scotland Cancer Centre
      • Leeds, Det Forenede Kongerige, LS9 7TF
        • St. James's Institute of Oncology
      • London, Det Forenede Kongerige, SW6 6JJ
        • The Royal Marsden NHS Trust
      • Manchester, Det Forenede Kongerige, M20 4BX
        • The Christie Hospital NHS Trust
      • Swansea, Det Forenede Kongerige, SA2 8QA
        • South Wales Cancer Institute, Singleton Hospital
  • Rumænien
      • Bucharest, Rumænien, 022328
        • Fundeni Clinical Institute - Urology Department
      • Bucharest, Rumænien, 041345
        • Dinu Uromedica
      • Bucharest, Rumænien, 050659
        • "Prof. Dr. Th. Burghele" Clinical Hospital, Urology Clinic
      • Cluj Napoca, Rumænien, 400015
        • "I. Chiricuta" Institute of Oncology
      • Cluj Napoca, Rumænien, 400016
        • E-URO Medical Center
      • Constanta, Rumænien, 900635
        • Provita Center SRL
      • Sibiu, Rumænien, 550245
        • Sibiu Clinical Country Hospital - Urology Clinic
      • Timisoara, Rumænien, 300239
        • Oncomed SRL
  • Ukraine
      • Cherkassy, Ukraine, 18009
        • Cherkassy Regional Oncology Center
      • Chernigov, Ukraine, 14029
        • Chernigov Regional Oncology Center
      • Dnepropetrovsk, Ukraine, 49005
        • Urology Department, Dnepropetrovsk State Medical Academy
      • Dnepropetrovsk, Ukraine, 49102
        • City General Hospital #4
      • Donetsk, Ukraine, 83092
        • Donetsk Regional Antitumor Center
      • Ivano-Frankovsk, Ukraine, 76000
        • Ivano-Frankovsk Regional Oncology Center
      • Kharkiv, Ukraine, 61037
        • Kharkiv Regional Urology and Nephrology Center
      • Kiev, Ukraine, 04053
        • Institute of Urology under the Academy of Medical Sciences of Ukraine, Department of Plastic and Supportive Urology
      • Kiev, Ukraine, 04053
        • Institute of Urology under the Academy of Medical Sciences of Ukraine, Urology Department
      • Lvov, Ukraine, 79031
        • State Regional Diagnostics and Treatment Oncology Center
      • Uzhorod, Ukraine, 88014
        • Regional Oncology 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

Inclusion Criteria:

  • Histologically or cytologically confirmed RCC (clear cell and papillary types)
  • Metastatic or inoperable locally advanced RCC
  • Eligible for therapy with IFN-alpha.
  • Measurable disease defined by at least 1 measurable lesion on CT scan (lesion diameter greater than or equal to 2.0 cm by a standard CT scanner or greater than or equal to 1.0 cm by a spiral CT scanner)
  • Favorable or moderate risk group prognosis by MSKCC (Motzer) criteria (score 0-2)
  • Karnofsky performance status greater than or equal to 70
  • Age greater than or equal to 18
  • Life expectancy greater than 3 months

  • Baseline blood counts:

    • Absolute neutrophil count (ANC) greater than or equal to 1.5 x 10^9/L
    • Platelets greater than or equal to 100 x 10^9/L
    • Haemoglobin greater than or equal to 100 g/L

  • Baseline blood chemistry levels:

    • Creatinine less than or equal to 1.5 x upper limit of normal (ULN)
    • Bilirubin less than or equal to 2 x ULN
    • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than or equal to 2.5 x ULN. AST and ALT allowed less than or equal to 5 x ULN for patients with liver metastases.
  • If fertile, patient will use effective method of contraception throughout the study
  • Willing and able to comply with the treatment and follow-up visits and examinations
  • Capable of understanding the parameters in the protocol and able to sign a written consent form

Exclusion Criteria:

  • Pregnant or breastfeeding women
  • Serious uncontrolled medical disorder or active infection ongoing or resolved within 2 weeks before first dose of study drug and that the investigator believes would impair the patient's ability to receive study drug
  • History of malignancy within 5 years or concurrent malignancy, except successfully treated non-melanoma skin cancer, cervical cancer in situ, ductal carcinoma in situ or lobular carcinoma in situ of breast may be included
  • History and/or signs of parenchymal brain metastases
  • Significant cardiac disease including: history (within 6 months) or current unstable angina pectoris, congestive heart failure (NYHA stage III-IV), myocardial infarction within 12 months, or uncontrolled arterial hypertension.
  • History of stroke within 5 years and/or transient ischemic attack within 6 months.
  • Acute illness or evidence of infection, including unexplained fever (>100.5ºF or 38.1ºC) within 2 weeks before start of treatment
  • Treatment with biological response modifiers within 3 weeks prior to the start of treatment and up to the End-of-Study visit
  • Treatment with beta-blockers, including topical therapy for glaucoma, within 5 days before start of treatment and during the 4-day ABR-217620/naptumomab estafenatox treatment
  • Treatment with systemic corticosteroids within 2 weeks before start of treatment or likely need for such treatment during the study
  • Active autoimmune disease requiring therapy or any history of systemic lupus erythematosus or rheumatoid arthritis
  • Known positive serology for HIV
  • Chronic hepatitis with advanced, decompensated hepatic disease or cirrhosis of the liver or history of chronic virus hepatitis or known virus carrying; patients who recovered from Hepatitis A are allowed
  • Treatment with anticoagulants within 2 weeks before start of treatment, except when used to maintain the patency of a central or peripheral venous line
  • Radiotherapy less than 4 weeks before start of treatment
  • Major surgery or tumor embolization less than 4 weeks before start of treatment
  • Previous exposure to murine monoclonal antibodies or known hypersensitivity to murine proteins
  • Currently on renal dialysis treatment
  • Known allergy or hypersensitivity to aminoglycosides and kanamycin
  • Previous systemic anti-tumor therapy for RCC (including immunotherapy with IFN-alpha or IL-2 or any chemotherapy) except sunitinib or other oral antiangiogenic therapy
  • Participation in any study with investigational drugs for RCC within 6 weeks

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: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 1
Medicin: ABR-217620/naptumomab estafenatox
10 mcg/kg or 15 mcg/kg, 5 minute bolus intravenous injection on 4 consecutive days / 8 week cycle repeated 3 times
Andre navne:
  • naptumomab estafenatox
Medicin: IFN-alpha
3 MIU, 6 MIU, and 9 MIU, subcutaneous or intramuscular injection 3 times / week
Andre navne:
  • Referon-A
Eksperimentel: Safety group
6-12 patients
Medicin: ABR-217620/naptumomab estafenatox
10 mcg/kg or 15 mcg/kg, 5 minute bolus intravenous injection on 4 consecutive days / 8 week cycle repeated 3 times
Andre navne:
  • naptumomab estafenatox
Medicin: IFN-alpha
3 MIU, 6 MIU, and 9 MIU, subcutaneous or intramuscular injection 3 times / week
Andre navne:
  • Referon-A
Andet: 2
Standard treatment with IFN-alpha without add-on of ABR-217620/naptumomab estafenatox
Medicin: IFN-alpha
3 MIU, 6 MIU, and 9 MIU, subcutaneous or intramuscular injection 3 times / week
Andre navne:
  • Referon-A

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Time to death
Tidsramme: every 12 weeks, including after a maximum of 18 months of study treatment
every 12 weeks, including after a maximum of 18 months of study treatment

Sekundære resultatmål

Resultatmål
Tidsramme
Progression-free survival time
Tidsramme: every 12 weeks for the 18-month treatment period and also every 12 weeks after the treatment period
every 12 weeks for the 18-month treatment period and also every 12 weeks after the treatment period
Objective tumor response rate
Tidsramme: every 12 weeks for the 18-month treatment period
every 12 weeks for the 18-month treatment period
Best overall response
Tidsramme: every 12 weeks for the 18-month treatment period
every 12 weeks for the 18-month treatment period
Duration of response
Tidsramme: every 12 weeks for the 18-month treatment period
every 12 weeks for the 18-month treatment period
Changes in sum of target lesions
Tidsramme: every 12 weeks for the 18-month treatment period
every 12 weeks for the 18-month treatment period
Immunological response in patients on combined treatment of ABR-217620/naptumomab estafenatox and IFN-alpha
Tidsramme: Weeks 1, 9, 17, 25, 73
Weeks 1, 9, 17, 25, 73
Vital signs
Tidsramme: every visit through Week 25, plus Week 73
every visit through Week 25, plus Week 73
Physical measurements
Tidsramme: Weeks 1, 9, 17, 25, 73
Weeks 1, 9, 17, 25, 73
Adverse events
Tidsramme: every visit through Week 73
every visit through Week 73
Laboratory safety assessments
Tidsramme: Weeks 1, 2, 3, 5, 9, 10, 13, 17, 18, 21, 25, and 73
Weeks 1, 2, 3, 5, 9, 10, 13, 17, 18, 21, 25, and 73
Pharmacokinetic parameters of ABR-217620/naptumomab estafenatox
Tidsramme: Weeks 1, 9, and 17
Weeks 1, 9, and 17

Samarbejdspartnere og efterforskere

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

Sponsor

Active Biotech AB

Efterforskere

  • Studieleder: Thore Nederman, PhD, Active Biotech AB

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. januar 2007

Primær færdiggørelse (Faktiske)

1. januar 2013

Studieafslutning (Faktiske)

1. januar 2013

Datoer for studieregistrering

Først indsendt

9. januar 2007

Først indsendt, der opfyldte QC-kriterier

9. januar 2007

Først opslået (Skøn)

11. januar 2007

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

22. juli 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

30. juni 2015

Sidst verificeret

1. juni 2014

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 06762004

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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