RAD001 Plus Bevacizumab in Metastatic Melanoma

Inclusion Criteria

• Histologically confirmed melanoma.
• Unresectable stage IV disease, or recurrent disease with metastases.
• Measurable disease (by Response Evaluation Criteria in Solid Tumors [RECIST]) or measurable skin lesions.
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2.
• Life expectancy >=12 weeks.
• Patients are allowed 0-2 prior treatment regimens containing chemotherapy and/or immunotherapy (interferon, interleukin 2).
• Women of childbearing potential must have a negative serum pregnancy test with 7 days before beginning treatment.
• Absolute neutrophil count (ANC) >=1500/µL, and platelets >=100,000/µL.
• Serum creatinine 1.5 ULN,
• Any acute or chronic uncontrolled infection/disorder.
• Non-malignant medical illnesses that are uncontrolled or whose control may be jeopardize by the treatment with the study therapy.
• Any acute or chronic uncontrolled infection/disorder.
• Non-malignant medical illnesses that are uncontrolled or whose control may be jeopardize by the treatment with the study therapy.
• Liver disease such as cirrhosis, chronic active hepatitis or chronic persistent hepatitis.
• Acute myocardial infarction (MI) with the previous 6 months.
• Clinically significant cardiovascular disease (e.g., uncontrolled hypertension, unstable angina, New York Heart Association [NYHA] Class II or greater congestive heart failure [CHF], serious cardiac arrhythmia requiring medication), or >= grade 2 vascular disease.
• Clinical history of hemoptysis or hematemesis.
• Clinical evidence or history of a bleeding diathesis or coagulopathy.
• Major surgical procedures, fine-needle aspirations, or core biopsies with 7 days of starting treatment.
• Patients with PEG tubes or G-tubes.
• Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of RAD001 (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection).
• Proteinuria at screening as demonstrated by either
• Urine protein: creatinine (UPC) ratio >= 1.0 at screening OR
• Urine dipstick for proteinuria >= 2+ (patients discovered to have >=2+ proteinuria on dipstick urinalysis at baseline should undergo a 24 hour urine collection and must demonstrate <= 1g of protein in 24 hours to be eligible).