Please select the eligibility criteria that correspond to the clinical trial below.
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.
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 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).


Options:
A: 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
B: Inclusion Criteria:

* Histologically and/or cytologically confirmed to have advanced renal cell carcinoma (RCC)
* Majority component of conventional clear-cell type is mandatory
* At least 1 measurable lesion (per RECIST)

Exclusion Criteria:

* Prior systemic treatment for RCC
* Evidence of current or prior central nervous system (CNS) metastases
* Cardiovascular disease
* Pregnant or nursing women
* Additional criteria applies
C: Inclusion Criteria:

* Male or female patients\>= 18 years of age;
* Patients with histological or cytological evidence of metastatic renal cell carcinoma mostly of all type,except for papillary;
* No prior systemic treatment (chemotherapy, immunotherapy, anti-angiogenic drugs, or treatment under evaluation) for metastatic renal cancer;
* No brain metastases revealed by MRI or CT-scan within 28 days prior to randomization. Patients with a history of brain metastases treated by surgery +/- radiation therapy can be included if they have normal brain MRI;
* E.C.O.G performance status =\<2;
* At least one measurable lesion using the RECIST criteria;
* Blood tests and renal and liver functions in the normal range with, in the 7 days prior to study entry, blood or serum values as follows:

Hemoglobin \> 8g/dl; Neutrophil count \> 1500\*10exp9/L; Platelets \> 100\*10exp9/L; Serum creatinine \< 200µmol/L; Total Bilirubin \< 1.5 times upper limit of normal; ALT and AST \< 2.5 times upper limit of normal or \< 5 ULN for patients with liver metastases, PT or INR \< 1.5 times upper limit of normal in the absence of anticoagulant therapy;

* Absence of proteinuria confirmed by urinary dipstick test
* Fertile women must use effective means of contraception
* Mandatory affiliation with a healthy security insurance
* Signed written informed consent.

Exclusion Criteria:

* Patient with pure papillary renal cell carcinoma
* Prior systemic treatment for metastatic renal cancer
* History of other malignancies, other than curatively treated in-situ carcinoma of the cervix or basal cell carcinoma of the skin, or any other curatively treated cancer with no sign of recurrence within 5 years prior to randomization
* Evidence of brain metastasis by computerized tomographic scan or MRI in the 28 days prior to randomization. Patients with history of brain metastases treated by exclusive brain therapy are not allowed to participate, even if brain MRI is normal
* Significant cardiovascular disease or uncontrolled hypertension while receiving appropriate medication (\>= 160 mm Hg systolic and/or \>= 90 mm Hg diastolic)
* Hepatic affection like chronic advanced hepatitis, liver cirrhosis or chronic hepatitis recently treated or in process of treatment by immunosuppressive agents, hepatitis auto-immune or history of auto-immune disease
* Major surgical procedure, open biopsy, or serious non healing wound within 28 days prior to randomization
* Uncontrolled hypercalcemia while receiving appropriate treatment
* Uncontrolled hypercholesterolemia or hypertriglyceridemia
* Patient under anti-vitamin K therapy
* Patient under strong CYP3A4 inhibitors
* Patient with severe neuropsychiatric disorder (or comitial crises)
* Patient included in another clinical trial, except for supportive care trials
* Pregnant or lactating women (mandatory negative serum or urinary pregnancy test at study entry for all women of childbearing potential)
D: Inclusion Criteria:

* Histologically documented metastatic renal cell cancer with a component of clear cell histology.
* Evidence of measurable disease.
* Patients with mRCC must have received no prior systemic first-line therapy or must have progressive disease per RECIST (version 1.0) after one prior systemic first line regimen for metastatic disease containing sunitinib, cytokine(s), or both.

Exclusion Criteria:

* Prior treatment for metastatic renal cell cancer with more that one systemic first line therapy.
* Major surgery less that 4 weeks or radiation less than 2 weeks of starting study drug.

Answer: A