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

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