0794GCC: Pentamidine in Treating Patients With Relapsed or Refractory Melanoma

You may be eligible if

• DISEASE CHARACTERISTICS:
• Histologically confirmed melanoma
• * Relapsed or refractory disease
• Tumor expresses wild-type p53
• Measurable S100B by immunohistochemistry
• Measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 20 mm by conventional techniques or as ≥ 10 mm by spiral CT scan
• Tumor amenable to biopsy
• Must have been evaluated for potentially curative resection
• No unstable or symptomatic brain metastases (e.g., seizures, headache related to tumor, or presence of neurologic deficits attributable to tumor)
• * Patients with stable brain metastases (by CT scan or MRI) are eligible provided they were treated with local therapy \> 4 weeks ago AND do not require maintenance steroid treatment
• PATIENT CHARACTERISTICS:
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2
• Life expectancy \> 12 weeks
• White Blood Cell count (WBC) ≥ 3,000/mcL
• Absolute Neutrophil Count (ANC) ≥ 1,500/mcL
• Platelet count ≥ 80,000/mcL
• Hemoglobin ≥ 8 g/dL
• Total bilirubin ≤ 1.5 times normal
• aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 times upper limit of normal
• Creatinine ≤ 1.5 times normal or creatinine clearance ≥ 60 mL/min
• Not pregnant or nursing
• Fertile patients must use effective contraception during and for ≥ 3 months after completion of study treatment
• Able to take oral medications on a regular basis
• No history of allergic reactions attributed to pentamidine
• Mean Corrected QT Interval (QTc) ≤ 470 msec (with Bazett's correction) on screening ECG
• No history of familial long QT syndrome
• Proteinuria ≤ 1 on two consecutive dipsticks taken ≥ 1 week apart
• No concurrent uncontrolled illness including, but not limited to, any of the following:
• * Hypertension
• * Ongoing or active infection
• * Symptomatic congestive heart failure
• * Unstable angina pectoris
• * Renal failure
• * Cardiac arrhythmia
• * Psychiatric illness/social situations that would limit compliance with study requirements
• PRIOR CONCURRENT THERAPY:
• Recovered from all prior therapy
• Any number of prior chemotherapy regimens allowed
• More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C)
• More than 4 weeks since prior radiotherapy or major surgery
• More than 30 days since prior participation in an investigational trial
• No concurrent medication that may markedly affect renal function (e.g., vancomycin, amphotericin, zoledronic acid)
• No concurrent combination antiretroviral therapy for HIV-positive patients
• No other concurrent investigational agents