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

June 30, 2015 updated by: 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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

526

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • 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
  • 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
  • Russian Federation
      • Arkhangelsk, Russian Federation
        • Arkhangelsk Regional Oncology Center
      • Chelyabinsk, Russian Federation, 454087
        • Chelyabinsk Regional Oncology Center
      • Kazan, Russian Federation, 420029
        • Republican Clinical Oncology Center
      • Kazan, Russian Federation, 420111
        • Kazan City Oncology Center
      • Moscow, Russian Federation, 115478
        • Russian Oncological Research Center n.a. N.N. Blokhin
      • Moscow, Russian Federation, 105425
        • Research Institute of Urology
      • Moscow, Russian Federation, 117997
        • Russian Research Center of Radiology
      • Obninsk, Russian Federation, 249036
        • Medical Radiology Research Center
      • Orenburg, Russian Federation, 460021
        • Orenburg Regional Clinical Oncology Center
      • St. Petersburg, Russian Federation, 191104
        • Leningrad Regional Oncological Center
      • St. Petersburg, Russian Federation, 193312
        • Municipal Aleksandrovskaya Hospital
      • St. Petersburg, Russian Federation, 194354
        • Municipal Multi-Speciality Hospital #2
      • St. Petersburg, Russian Federation, 196247
        • Municipal Hospital #26
      • St. Petersburg, Russian Federation, 197022
        • Municipal Clinical Oncology Center
      • St. Petersburg, Russian Federation, 197758
        • Central Research Institute of Roentgenology and Radiology
      • St. Petersburg, Russian Federation, 197758
        • Research Institute of Oncology n.a. Professor N.N. Petrov
      • St. Petersburg, Russian Federation, 198205
        • Municipal Hospital #15
      • Stavropol, Russian Federation, 355047
        • Stavropol Territorial Clinical Oncology Center
      • Yaroslavl, Russian Federation, 150054
        • Regional Clinical Oncology Hospital
  • 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
  • United Kingdom
      • Cambridge, United Kingdom, CB2 0QQ
        • Addenbrooke's Hospital, Cambridge Clinical Trials Centre
      • Derby, United Kingdom, DE1 2QY
        • Derby Hospital NHS Trust
      • Glasgow, United Kingdom, G12 0YN
        • The Beatson West of Scotland Cancer Centre
      • Leeds, United Kingdom, LS9 7TF
        • St. James's Institute of Oncology
      • London, United Kingdom, SW6 6JJ
        • The Royal Marsden NHS Trust
      • Manchester, United Kingdom, M20 4BX
        • The Christie Hospital NHS Trust
      • Swansea, United Kingdom, SA2 8QA
        • South Wales Cancer Institute, Singleton Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: 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
Other Names:
  • naptumomab estafenatox
Drug: IFN-alpha
3 MIU, 6 MIU, and 9 MIU, subcutaneous or intramuscular injection 3 times / week
Other Names:
  • Referon-A
Experimental: Safety group
6-12 patients
Drug: 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
Other Names:
  • naptumomab estafenatox
Drug: IFN-alpha
3 MIU, 6 MIU, and 9 MIU, subcutaneous or intramuscular injection 3 times / week
Other Names:
  • Referon-A
Other: 2
Standard treatment with IFN-alpha without add-on of ABR-217620/naptumomab estafenatox
Drug: IFN-alpha
3 MIU, 6 MIU, and 9 MIU, subcutaneous or intramuscular injection 3 times / week
Other Names:
  • Referon-A

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time to death
Time Frame: 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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Active Biotech AB

Investigators

  • Study Director: Thore Nederman, PhD, Active Biotech AB

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

January 9, 2007

First Submitted That Met QC Criteria

January 9, 2007

First Posted (Estimate)

January 11, 2007

Study Record Updates

Last Update Posted (Estimate)

July 22, 2015

Last Update Submitted That Met QC Criteria

June 30, 2015

Last Verified

June 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 06762004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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