0794GCC: Pentamidine in Treating Patients With Relapsed or Refractory Melanoma
Condition: Melanoma (Skin)
MeSH terms: Melanoma
Intervention: pentamidine
Intervention MeSH terms: Pentamidine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: This is an open label Phase II trial that will utilize a Simon two stage acquisition of patients with evaluable relapsed and/or refractory melanoma.
Masking: None (Open Label)
Enrollment: 6.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: recurrent melanoma

Summary:

      RATIONALE: Drugs used in chemotherapy, such as pentamidine, work in different ways to stop
      the growth of tumor cells, either by killing the cells or by stopping them from dividing.

      PURPOSE: This phase II trial is studying how well pentamidine works in treating patients with
      relapsed or refractory melanoma.
    

Eligibility criteria:

        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