Genetic Variates of Response to Cisplatin, Vinblastine, and Temozolomide (CVT) in Patients With Metastatic Melanoma
Condition: Melanoma; Skin Cancer
MeSH terms: Melanoma; Skin Neoplasms
Intervention: Cisplatin, Vinblastine, Temozolomide
Intervention description: Patients will receive CVT chemotherapy which consists of the following:
Cisplatin 25 mg/m2 given intravenously on days 2-5 Vinblastine 1.5 mg/m2 given as an intravenous push on days 2-5 Temozolomide 150 mg/m2 given orally on days 1-5. In patients who cannot receive temozolomide, dacarbazine can be used instead. Dacarbazine will be given at 800 mg/m2 IV on day 1.
Intervention MeSH terms: Temozolomide; Vinblastine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 7.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: skin cancer; CISPLATIN; TEMOZOLOMIDE; VINBLASTINE; 09-017

Summary:

      The investigators want to learn to predict which tumors will respond to CVT chemotherapy. CVT
      is a combination of three drugs - cisplatin, vinblastine, and temozolomide. We and other
      investigators have used CVT in melanoma patients and found that tumors got significantly
      smaller in 30-40% of cases. In this study, the investigators want to get a precise idea of
      how many patients will respond to CVT. Also they want to test which genes in the tumor are
      turned on and which are turned off. We hope this will teach us to know in the future which
      tumors will respond to CVT.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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
             administration.

        Exclusion Criteria:

          -  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
             intake

          -  Serious infection requiring antibiotics, or nonmalignant medical illnesses that are
             uncontrolled or whose control might be jeopardized by the complications of this
             therapy.

          -  History of HIV infection even if on HAART

          -  Immunosuppressive drugs

          -  High dose vitamins and herbs

          -  Other on-going investigational therapy, concurrent chemotherapy, immunotherapy or
             radiotherapy.