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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 bijgewerkt door: 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).

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Werkelijk)

526

Fase

  • Fase 2
  • Fase 3

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 1
Geneesmiddel: 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
Andere namen:
  • naptumomab estafenatox
Geneesmiddel: IFN-alpha
3 MIU, 6 MIU, and 9 MIU, subcutaneous or intramuscular injection 3 times / week
Andere namen:
  • Referon-A
Experimenteel: Safety group
6-12 patients
Geneesmiddel: 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
Andere namen:
  • naptumomab estafenatox
Geneesmiddel: IFN-alpha
3 MIU, 6 MIU, and 9 MIU, subcutaneous or intramuscular injection 3 times / week
Andere namen:
  • Referon-A
Ander: 2
Standard treatment with IFN-alpha without add-on of ABR-217620/naptumomab estafenatox
Geneesmiddel: IFN-alpha
3 MIU, 6 MIU, and 9 MIU, subcutaneous or intramuscular injection 3 times / week
Andere namen:
  • Referon-A

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Tijdsspanne
Time to death
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Tijdsspanne
Progression-free survival time
Tijdsspanne: 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
Tijdsspanne: every 12 weeks for the 18-month treatment period
every 12 weeks for the 18-month treatment period
Best overall response
Tijdsspanne: every 12 weeks for the 18-month treatment period
every 12 weeks for the 18-month treatment period
Duration of response
Tijdsspanne: every 12 weeks for the 18-month treatment period
every 12 weeks for the 18-month treatment period
Changes in sum of target lesions
Tijdsspanne: 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
Tijdsspanne: Weeks 1, 9, 17, 25, 73
Weeks 1, 9, 17, 25, 73
Vital signs
Tijdsspanne: every visit through Week 25, plus Week 73
every visit through Week 25, plus Week 73
Physical measurements
Tijdsspanne: Weeks 1, 9, 17, 25, 73
Weeks 1, 9, 17, 25, 73
Adverse events
Tijdsspanne: every visit through Week 73
every visit through Week 73
Laboratory safety assessments
Tijdsspanne: 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
Tijdsspanne: Weeks 1, 9, and 17
Weeks 1, 9, and 17

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Active Biotech AB

Onderzoekers

  • Studie directeur: Thore Nederman, PhD, Active Biotech AB

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 januari 2007

Primaire voltooiing (Werkelijk)

1 januari 2013

Studie voltooiing (Werkelijk)

1 januari 2013

Studieregistratiedata

Eerst ingediend

9 januari 2007

Eerst ingediend dat voldeed aan de QC-criteria

9 januari 2007

Eerst geplaatst (Schatting)

11 januari 2007

Updates van studierecords

Laatste update geplaatst (Schatting)

22 juli 2015

Laatste update ingediend die voldeed aan QC-criteria

30 juni 2015

Laatst geverifieerd

1 juni 2014

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 06762004

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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