RO4929097 in Treating Patients With Stage IIIB, Stage IIIC, or Stage IV Melanoma That Can Be Removed by Surgery

You may be eligible if

• Histologically or cytologically confirmed melanoma
• * Stage IIIB, IIIC, or IV disease
• * Disease that is deemed resectable by surgical consultation
• * Patients must agree to pretreatment biopsies of their tumor
• Measurable disease defined as ≥ 1 lesion that can be accurately measured in ≥ 1 dimension (longest diameter to be recorded) as ≥ 20 mm by conventional techniques OR as ≥ 10 mm by spiral CT scan
• * Measurable lesions must be deemed resectable
• * Skin metastases must be photographed and measured
• * No non-target disease
• No known brain metastases
• Life expectancy \> 3 months
• ECOG performance status 0-2 (Karnofsky 60-100%)
• WBC ≥ 3,000/mm³
• ANC ≥ 1,500/mm³
• Platelet count ≥ 75,000/mm³
• Hemoglobin \> 10 g/dL
• Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
• AST and ALT ≤ 2.5 times ULN
• Creatinine ≤ 1.5 times ULN OR creatinine clearance ≥ 60 mL/min
• Fertile patients must agree to use 2 forms of contraception (i.e., barrier contraception and 1 other method of contraception) for ≥ 4 weeks prior to, during, and for ≥ 12 months post-treatment
• Negative pregnancy test
• Not pregnant or nursing
• No history of allergic reactions attributed to compounds of similar chemical or biological composition of gamma-secretase inhibitor RO4929097 or other agents used in the study
• No malabsorption syndrome or other condition that would interfere with intestinal absorption
• Able to swallow tablets
• No known history of hepatitis or have a history of liver disease or other forms of cirrhosis
• No uncontrolled hypocalcemia, hypomagnesemia, hyponatremia, hypophosphatemia, or hypokalemia despite adequate electrolyte supplementation
• No uncontrolled intercurrent illness including, but not limited to, any of the following:
• * Ongoing or active infection
• * Symptomatic congestive heart failure
• * Unstable angina pectoris
• * Cardiac arrhythmia other than chronic
• * Unstable atrial fibrillation
• * Psychiatric illness and/or social situations that would limit compliance with study requirements
• No baseline QTcF \> 450 msec (male) or QTcF \> 470 msec (female)
• No history of cancer within the past 5 years except curatively treated basal or squamous cell cancer of the skin, in situ cervical cancer, or lobular carcinoma in situ of the breast
• No other concurrent anticancer agents or therapies
• More than 4 weeks since prior immunotherapy or local radiotherapy and recovered
• No prior chemotherapy for melanoma
• No concurrent medications with narrow therapeutic indices that are metabolized by cytochrome P450 (CYP450), including warfarin sodium (Coumadin®)
• No concurrent medications that are strong inducers/inhibitors or substrates of CYP3A4
• No concurrent combination antiretroviral therapy for HIV-positive patients
• No concurrent ketoconazole or grapefruit juice while taking gamma-secretase inhibitor RO4929097
• No concurrent granulocyte colony-stimulating factors
• No other concurrent investigational agents