Personalized Targeted Inhibitors Treatment in Renal Cell Cancer

This is an interventional treatment trial for Carcinoma, Renal Cell focused on measuring Renal Cell Carcinoma, RCC, Personalized therapy, targeted inhibitors Read More

Inclusion Criteria:

• Subjects may be included in the study only if they meet all of the following inclusion criteria:

  • Pathologically confirmed renal cell carcinoma.

  • No prior systemic and/or investigative therapy of any kind.

    • Patients with primary tumor in place are strongly encouraged to undergo nephrectomy prior to initiation of study agent.
    • Prior palliative radiotherapy to metastatic lesion(s) is permitted. Patient must have adequately recovered from the acute toxicities of this treatment.
    • All major surgery of any type and/or radiotherapy must be completed at least 4 weeks prior to registration.
  • Must have progressive metastatic disease
  • ECOG performance status ≤2
  • Women of childbearing potential and male patients must use acceptable methods of contraception-tubal ligation, vasectomy, barrier contraceptive with spermicide-while on study and for 3 months after the last dose of study therapy. Oral, implantable, or injectable contraceptives may be affected by cytochrome P450 interactions, and are therefore not considered effective for this study.
  • Age ≥18 years

  • Required Initial Laboratory Values:

    • Granulocytes ≥1,500/µL
    • Platelet Count ≥100,000/µL
    • Hemoglobin ≥9 g/dL
    • AST/ALT ≤ 2.5 times the upper limit of normal (ULN)
    • Alk. Phos.≤ 2.5 x ULN
    • Serum bilirubin ≤ 1.5 x ULN
    • Amylase/Lipase within normal range
    • Urinalysis≤ 1+ protein
    • T3T4 TSH - within normal range
    • Pregnancy test for women - Negative
    • Serum creatinine ≤ 1.5 x ULN
    • Electrocardiogram (ECG) - no active ischemia
    • Echocardiogram ejection fraction ≥40%
    • Pulmonary function tests
    • Fasting serum cholesterol ≤300 mg/dL OR ≤7.75 mmol/L AND fasting triglycerides ≤2.5 x ULN. NOTE: In case one or both of these thresholds are exceeded, the patient can only be included after initiation of appropriate lipid lowering medication.
  • Signed informed consent prior to the performance of any study-specific procedures

Exclusion Criteria:

• Ongoing hemoptysis, or cerebrovascular accident within 12 months prior to study entry, or peripheral vascular disease with claudication occurring upon walking less than one city block, or history of clinically significant bleeding.
• Deep venous thrombosis or pulmonary embolus within 12 months prior to study entry and no ongoing need for full-dose oral or parenteral anticoagulation. For maintenance of catheter patency daily prophylactic aspirin or low-dose coumadin (1-2 mg) is allowed.
• Evidence of current central nervous system (CNS) metastases. All patients must undergo a CT scan of the brain (with contrast, if possible) within 42 days prior to registration. Any imaging abnormality indicative of active CNS metastases will exclude the patient from the study.
• Significant cardiovascular disease defined as congestive heart failure (New York Heart Association Class II, II or IV) angina pectoris requiring nitrate therapy, or recent myocardial infarction (within the preceding 6 months prior to study entry).
• Uncontrolled hypertension (defined as blood pressure of ≥160 mmHg systolic and/or ≥90 mmHg diastolic on medication). Document over 48 hours with minimum of 3 readings.
• Ongoing requirement for systemic corticosteroid therapy (except replacement therapy for adrenal insufficiency) or other immunosuppressants are not permitted. Topical and/or inhaled steroids are allowed.