ABR-217620/Naptumomab Estafenatox With Interferon-alpha (IFN-alpha) Compared to IFN-alpha Alone in Patients With Advanced Renal Cell Carcinoma
NCT ID: NCT00420888
Last Updated: 2015-07-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
526 participants
INTERVENTIONAL
2007-01-31
2013-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Safety group
6-12 patients
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
IFN-alpha
3 MIU, 6 MIU, and 9 MIU, subcutaneous or intramuscular injection 3 times / week
1
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
IFN-alpha
3 MIU, 6 MIU, and 9 MIU, subcutaneous or intramuscular injection 3 times / week
2
Standard treatment with IFN-alpha without add-on of ABR-217620/naptumomab estafenatox
IFN-alpha
3 MIU, 6 MIU, and 9 MIU, subcutaneous or intramuscular injection 3 times / week
Interventions
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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
IFN-alpha
3 MIU, 6 MIU, and 9 MIU, subcutaneous or intramuscular injection 3 times / week
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Active Biotech AB
INDUSTRY
Responsible Party
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Principal Investigators
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Thore Nederman, PhD
Role: STUDY_DIRECTOR
Active Biotech AB
Locations
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Department of Chemotherapy, University General Hospital for Active Treatment "Georgi Stranski"
Pleven, , Bulgaria
1st Internal Department District Dispensary for Cancer Diseases with Inpatient Hospital
Plovdiv, , Bulgaria
Multifile Hospital "Aleksandrovska", Urology Clinic, Department of Oncourology
Sofia, , Bulgaria
Oncology Clinic, University General Hospital for Active Treatment "Tzaritza Yoanna"
Sofia, , Bulgaria
Urology Clinic, General Hospital for Active Treatment "St. Anna"
Varna, , Bulgaria
Department of Chemotherapy, Inter-district Dispensary for Cancer Diseases with Inpatient Hospital
Veliko Tarnovo, , Bulgaria
Fundeni Clinical Institute - Urology Department
Bucharest, , Romania
Dinu Uromedica
Bucharest, , Romania
"Prof. Dr. Th. Burghele" Clinical Hospital, Urology Clinic
Bucharest, , Romania
"I. Chiricuta" Institute of Oncology
Cluj-Napoca, , Romania
E-URO Medical Center
Cluj-Napoca, , Romania
Provita Center SRL
Constanța, , Romania
Sibiu Clinical Country Hospital - Urology Clinic
Sibiu, , Romania
Oncomed SRL
Timișoara, , Romania
Arkhangelsk Regional Oncology Center
Arkhangelsk, , Russia
Chelyabinsk Regional Oncology Center
Chelyabinsk, , Russia
Republican Clinical Oncology Center
Kazan', , Russia
Kazan City Oncology Center
Kazan', , Russia
Research Institute of Urology
Moscow, , Russia
Russian Oncological Research Center n.a. N.N. Blokhin
Moscow, , Russia
Russian Research Center of Radiology
Moscow, , Russia
Medical Radiology Research Center
Obninsk, , Russia
Orenburg Regional Clinical Oncology Center
Orenburg, , Russia
Leningrad Regional Oncological Center
Saint Petersburg, , Russia
Municipal Aleksandrovskaya Hospital
Saint Petersburg, , Russia
Municipal Multi-Speciality Hospital #2
Saint Petersburg, , Russia
Municipal Hospital #26
Saint Petersburg, , Russia
Municipal Clinical Oncology Center
Saint Petersburg, , Russia
Central Research Institute of Roentgenology and Radiology
Saint Petersburg, , Russia
Research Institute of Oncology n.a. Professor N.N. Petrov
Saint Petersburg, , Russia
Municipal Hospital #15
Saint Petersburg, , Russia
Stavropol Territorial Clinical Oncology Center
Stavropol, , Russia
Regional Clinical Oncology Hospital
Yaroslavl, , Russia
Cherkassy Regional Oncology Center
Cherkassy, , Ukraine
Chernigov Regional Oncology Center
Chernihiv, , Ukraine
Urology Department, Dnepropetrovsk State Medical Academy
Dnipro, , Ukraine
City General Hospital #4
Dnipro, , Ukraine
Donetsk Regional Antitumor Center
Donetsk, , Ukraine
Ivano-Frankovsk Regional Oncology Center
Ivano-Frankivsk, , Ukraine
Kharkiv Regional Urology and Nephrology Center
Kharkiv, , Ukraine
Institute of Urology under the Academy of Medical Sciences of Ukraine, Department of Plastic and Supportive Urology
Kiev, , Ukraine
Institute of Urology under the Academy of Medical Sciences of Ukraine, Urology Department
Kiev, , Ukraine
State Regional Diagnostics and Treatment Oncology Center
Lviv, , Ukraine
Regional Oncology Center
Uzhhorod, , Ukraine
Addenbrooke's Hospital, Cambridge Clinical Trials Centre
Cambridge, , United Kingdom
Derby Hospital NHS Trust
Derby, , United Kingdom
The Beatson West of Scotland Cancer Centre
Glasgow, , United Kingdom
St. James's Institute of Oncology
Leeds, , United Kingdom
The Royal Marsden NHS Trust
London, , United Kingdom
The Christie Hospital NHS Trust
Manchester, , United Kingdom
South Wales Cancer Institute, Singleton Hospital
Swansea, , United Kingdom
Countries
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References
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Hawkins R, Gore M, Shparyk Y, Bondar V, Gladkov O, Ganev T, Harza M, Polenkov S, Bondarenko I, Karlov P, Karyakin O, Khasanov R, Hedlund G, Forsberg G, Nordle Ö, Eisen T. A randomized phase 2/3 study of naptumomab estafenatox plus IFN-α vs IFN-α in advanced renal cell carcinoma. ASCO Annual Meeting 2013; Abstract ID: 3073.
Eisen T, Hedlund G, Forsberg G, Nordle Ö, Hawkins R. Baseline biomarker trend analysis of a randomized phase 2/3 study of naptumomab estafenatox plus IFN-α vs IFN-α in advanced renal cell carcinoma. European Cancer Congress (ECCO) 2013; Abstract ID: 2710.
Elkord E, Burt DJ, Sundstedt A, Nordle O, Hedlund G, Hawkins RE. Immunological response and overall survival in a subset of advanced renal cell carcinoma patients from a randomized phase 2/3 study of naptumomab estafenatox plus IFN-alpha versus IFN-alpha. Oncotarget. 2015 Feb 28;6(6):4428-39. doi: 10.18632/oncotarget.2922.
Aldin A, Besiroglu B, Adams A, Monsef I, Piechotta V, Tomlinson E, Hornbach C, Dressen N, Goldkuhle M, Maisch P, Dahm P, Heidenreich A, Skoetz N. First-line therapy for adults with advanced renal cell carcinoma: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 May 4;5(5):CD013798. doi: 10.1002/14651858.CD013798.pub2.
Other Identifiers
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06762004
Identifier Type: -
Identifier Source: org_study_id
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