Genetic Variates of Response to Cisplatin, Vinblastine, and Temozolomide (CVT) in Patients With Metastatic Melanoma
- Age ≥ 18 years
- Histologic proof of melanoma reviewed and confirmed at MSKCC
- Patients must have stage IV melanoma or recurrent stage IIIb or IIIc melanoma.
Patients who are potentially respectable will be eligible.
- Measurable disease (RECIST criteria). Patients must have a tumor amenable to biopsy
for oligonucleotide microarray analysis and for immunohistochemistry. A pre-treatment
biopsy is required; a fine needle aspirate is not adequate.
- No prior cytotoxic chemotherapy for melanoma. Prior immunotherapy or anti-angiogenic
therapy is allowed.
- No other concurrent chemotherapy, immunotherapy, or radiotherapy
- ECOG performance status ≤ 1
- Adequate organ function defined as follows: ANC >1500/mm3, Platelets >130,000/mm3,
calculated creatinine clearance ≥60 ml/minute (Cockcroft & Gault).
- Adequate cardiac function to tolerate the hydration needed for cisplatin
- History of CNS metastases unless brain metastases have been resected or successfully
treated with stereotactic radiosurgery and the patient has been free from CNS
recurrence for 3 months.
- Uveal melanoma primary
- Patients who have had prior anti-CTLA4 monoclonal antibody treatment must have been
off treatment for at least 4 months and have signs of progression of disease.
- Frequent vomiting or medical conditions that could interfere with oral medication
- Serious infection requiring antibiotics, or nonmalignant medical illnesses that are
uncontrolled or whose control might be jeopardized by the complications of this
- History of HIV infection even if on HAART
- Immunosuppressive drugs
- High dose vitamins and herbs
- Other on-going investigational therapy, concurrent chemotherapy, immunotherapy or