ABR-217620/Naptumomab Estafenatox With Interferon-alpha (IFN-alpha) Compared to IFN-alpha Alone in Patients With Advanced Renal Cell Carcinoma
Information source: Active Biotech AB
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Renal Cell Carcinoma
Intervention: ABR-217620/naptumomab estafenatox (Drug); IFN-alpha (Drug)
Phase: Phase 2/Phase 3
Status: Completed
Sponsored by: Active Biotech AB Official(s) and/or principal investigator(s): Thore Nederman, PhD, Study Director, Affiliation: Active Biotech AB
Summary
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).
Clinical Details
Official title: 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.
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Time to death
Secondary outcome: Progression-free survival timeObjective tumor response rate Best overall response Duration of response Changes in sum of target lesions Immunological response in patients on combined treatment of ABR-217620/naptumomab estafenatox and IFN-alpha Vital signs Physical measurements Adverse events Laboratory safety assessments Pharmacokinetic parameters of ABR-217620/naptumomab estafenatox
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Department of Chemotherapy, University General Hospital for Active Treatment "Georgi Stranski", Pleven 5800, Bulgaria
1st Internal Department District Dispensary for Cancer Diseases with Inpatient Hospital, Plovdiv 4004, Bulgaria
Multifile Hospital "Aleksandrovska", Urology Clinic, Department of Oncourology, Sofia 1431, Bulgaria
Oncology Clinic, University General Hospital for Active Treatment "Tzaritza Yoanna", Sofia 1527, Bulgaria
Urology Clinic, General Hospital for Active Treatment "St. Anna", Varna 9002, Bulgaria
Department of Chemotherapy, Inter-district Dispensary for Cancer Diseases with Inpatient Hospital, Veliko Tarnovo 5000, Bulgaria
"Prof. Dr. Th. Burghele" Clinical Hospital, Urology Clinic, Bucharest 050659, Romania
Dinu Uromedica, Bucharest 041345, Romania
Fundeni Clinical Institute - Urology Department, Bucharest 022328, Romania
"I. Chiricuta" Institute of Oncology, Cluj Napoca 400015, Romania
E-URO Medical Center, Cluj Napoca 400016, Romania
Provita Center SRL, Constanta 900635, Romania
Sibiu Clinical Country Hospital - Urology Clinic, Sibiu 550245, Romania
Oncomed SRL, Timisoara 300239, Romania
Arkhangelsk Regional Oncology Center, Arkhangelsk, Russian Federation
Chelyabinsk Regional Oncology Center, Chelyabinsk 454087, Russian Federation
Kazan City Oncology Center, Kazan 420111, Russian Federation
Republican Clinical Oncology Center, Kazan 420029, Russian Federation
Research Institute of Urology, Moscow 105425, Russian Federation
Russian Oncological Research Center n.a. N.N. Blokhin, Moscow 115478, Russian Federation
Russian Research Center of Radiology, Moscow 117997, Russian Federation
Medical Radiology Research Center, Obninsk 249036, Russian Federation
Orenburg Regional Clinical Oncology Center, Orenburg 460021, Russian Federation
Central Research Institute of Roentgenology and Radiology, St. Petersburg 197758, Russian Federation
Leningrad Regional Oncological Center, St. Petersburg 191104, Russian Federation
Municipal Aleksandrovskaya Hospital, St. Petersburg 193312, Russian Federation
Municipal Clinical Oncology Center, St. Petersburg 197022, Russian Federation
Municipal Hospital #15, St. Petersburg 198205, Russian Federation
Municipal Hospital #26, St. Petersburg 196247, Russian Federation
Municipal Multi-Speciality Hospital #2, St. Petersburg 194354, Russian Federation
Research Institute of Oncology n.a. Professor N.N. Petrov, St. Petersburg 197758, Russian Federation
Stavropol Territorial Clinical Oncology Center, Stavropol 355047, Russian Federation
Regional Clinical Oncology Hospital, Yaroslavl 150054, Russian Federation
Cherkassy Regional Oncology Center, Cherkassy 18009, Ukraine
Chernigov Regional Oncology Center, Chernigov 14029, Ukraine
City General Hospital #4, Dnepropetrovsk 49102, Ukraine
Urology Department, Dnepropetrovsk State Medical Academy, Dnepropetrovsk 49005, Ukraine
Donetsk Regional Antitumor Center, Donetsk 83092, Ukraine
Ivano-Frankovsk Regional Oncology Center, Ivano-Frankovsk 76000, Ukraine
Kharkiv Regional Urology and Nephrology Center, Kharkiv 61037, Ukraine
Institute of Urology under the Academy of Medical Sciences of Ukraine, Department of Plastic and Supportive Urology, Kiev 04053, Ukraine
Institute of Urology under the Academy of Medical Sciences of Ukraine, Urology Department, Kiev 04053, Ukraine
State Regional Diagnostics and Treatment Oncology Center, Lvov 79031, Ukraine
Regional Oncology Center, Uzhorod 88014, Ukraine
Addenbrooke's Hospital, Cambridge Clinical Trials Centre, Cambridge CB2 0QQ, United Kingdom
Derby Hospital NHS Trust, Derby DE1 2QY, United Kingdom
The Beatson West of Scotland Cancer Centre, Glasgow G12 0YN, United Kingdom
St. James's Institute of Oncology, Leeds LS9 7TF, United Kingdom
The Royal Marsden NHS Trust, London SW6 6JJ, United Kingdom
The Christie Hospital NHS Trust, Manchester M20 4BX, United Kingdom
South Wales Cancer Institute, Singleton Hospital, Swansea SA2 8QA, United Kingdom
Additional Information
Starting date: January 2007
Last updated: June 30, 2015
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