A Randomized, Open-label, Multi-center, Phase II/III Study on Treatment With ABR-217620 Combined With IFN-alpha vs. 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 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