Temozolomide and Bevacizumab in Treating Patients With Metastatic Melanoma of the Eye

This is an interventional treatment trial for Intraocular Melanoma focused on measuring ciliary body and choroid melanoma, medium/large size, ciliary body and choroid melanoma, small size, iris melanoma, metastatic intraocular melanoma, stage IV intraocular melanoma Read More

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed uveal melanoma

  • Metastatic disease
• Measurable disease, defined as ≥ 1 measurable lesion as measured by RECIST criteria
• No curative surgical treatment envisaged
• No active brain metastases (if clinical suspicion, must have a brain CT scan within 28 days)

PATIENT CHARACTERISTICS:

• WHO performance status (PS) 0-1 OR Karnofsky PS 70-100%
• Life expectancy ≥ 12 weeks
• Hemoglobin ≥ 10 g/dL
• Absolute neutrophil count ≥ 1,500/mm^3
• Platelet count ≥ 100,000/mm^3
• Serum creatinine ≤ 1.5 times upper limit of normal (ULN) OR calculated creatinine clearance ≥ 50 mL/min
• Proteinuria < 2+ on urinary dipstick OR 24-hour proteinuria ≤ 1 g
• Total bilirubin ≤ 1.5 times ULN
• AST/ALT ≤ 2.5 times ULN
• Lactate dehydrogenase ≤ 5 times ULN
• INR and PT ≤ 1.5 times ULN
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for 6 months after completion of study treatment
• No uncontrolled active disease or at risk of bleeding, ongoing infection, or clotting disorder
• No other cancer except for skin carcinomas and cervical carcinoma in situ
• No pre-existing peripheral neuropathy, > grade 2 (NCI CTC-AE)
• No failure to comply with the medical follow-up of the study for geographical, social, or psychological reasons
• No recent thrombophlebitis or pulmonary embolism within the past 6 months
• No uncontrolled hypertension (systolic BP > 150 mm Hg and/or diastolic BP > 100 mm Hg)

• No concurrent active cardiovascular disease, uncontrolled by medical treatment within the past 6 months, including any of the following:

  • Unstable angina
  • Severe hypertension
  • Severe arrhythmia
• No unhealed wound, active peptic ulcer, bone fracture, history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months
• No known hypersensitivity to bevacizumab, temozolomide, or their excipients

PRIOR CONCURRENT THERAPY:

• No prior chemotherapy for metastatic disease
• At least 24 hours since insertion of central infusion port
• More than 5 days since prior non-hepatic biopsy or aspiration cytology
• More than 10 days since prior aspirin (> 325 mg/day), clopidogrel (> 75 mg/day), or full-dose oral or parenteral anticoagulant therapy, except prophylactic anticoagulant therapy prior to inclusion in the study
• More than 14 days since prior laparoscopic liver biopsy
• More than 28 days since prior major surgery
• More than 28 days since prior participation in another study with experimental treatment
• No other concurrent anticancer treatment