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

• Status: Terminated
• Trial end date: 2012-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Edward Sausville; University of Maryland, Baltimore
• Collaborator: National Cancer Institute (NCI)
• Treatments: Pentamidine

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