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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 giugno 2015 aggiornato da: 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).

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

526

Fase

  • Fase 2
  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 1
Droga: 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
Altri nomi:
  • naptumomab estafenatox
Droga: IFN-alpha
3 MIU, 6 MIU, and 9 MIU, subcutaneous or intramuscular injection 3 times / week
Altri nomi:
  • Referon-A
Sperimentale: Safety group
6-12 patients
Droga: 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
Altri nomi:
  • naptumomab estafenatox
Droga: IFN-alpha
3 MIU, 6 MIU, and 9 MIU, subcutaneous or intramuscular injection 3 times / week
Altri nomi:
  • Referon-A
Altro: 2
Standard treatment with IFN-alpha without add-on of ABR-217620/naptumomab estafenatox
Droga: IFN-alpha
3 MIU, 6 MIU, and 9 MIU, subcutaneous or intramuscular injection 3 times / week
Altri nomi:
  • Referon-A

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Lasso di tempo
Time to death
Lasso di tempo: 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

Misure di risultato secondarie

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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Active Biotech AB

Investigatori

  • Direttore dello studio: Thore Nederman, PhD, Active Biotech AB

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 gennaio 2007

Completamento primario (Effettivo)

1 gennaio 2013

Completamento dello studio (Effettivo)

1 gennaio 2013

Date di iscrizione allo studio

Primo inviato

9 gennaio 2007

Primo inviato che soddisfa i criteri di controllo qualità

9 gennaio 2007

Primo Inserito (Stima)

11 gennaio 2007

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

22 luglio 2015

Ultimo aggiornamento inviato che soddisfa i criteri QC

30 giugno 2015

Ultimo verificato

1 giugno 2014

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 06762004

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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