Status:
COMPLETED
ABR-217620/Naptumomab Estafenatox With Interferon-alpha (IFN-alpha) Compared to IFN-alpha Alone in Patients With Advanced Renal Cell Carcinoma
Lead Sponsor:
Active Biotech AB
Conditions:
Renal Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief 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 belongin...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2013
Estimated Enrollment :
526 Patients enrolled
Trial Details
Trial ID
NCT00420888
Start Date
January 1 2007
End Date
January 1 2013
Last Update
July 22 2015
Active Locations (51)
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1
Department of Chemotherapy, University General Hospital for Active Treatment "Georgi Stranski"
Pleven, Bulgaria, 5800
2
1st Internal Department District Dispensary for Cancer Diseases with Inpatient Hospital
Plovdiv, Bulgaria, 4004
3
Multifile Hospital "Aleksandrovska", Urology Clinic, Department of Oncourology
Sofia, Bulgaria, 1431
4
Oncology Clinic, University General Hospital for Active Treatment "Tzaritza Yoanna"
Sofia, Bulgaria, 1527