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