Melanoma (Skin) Clinical Trial
Official title:
Treatment of Melanoma With Wild-type p53 and Detectable S100B Using Pentamidine: a Phase II Trial With Correlative Biomarker Endpoints
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.
OBJECTIVES:
Primary
- To determine the response rate in patients with relapsed or refractory melanoma that
expresses wild-type p53 and S100 calcium binding protein B (S100B) treated with
pentamidine.
Secondary
- To observe the effect of this drug on the expression of S100B and p21 in tumor biopsy
samples.
- To observe the effect of this drug on S100B detectable in serum.
- To observe the time to progression in these patients.
- To assess the toxicities associated with the administration of this drug in these
patients.
OUTLINE: Patients receive pentamidine IV over 2 hours 5 days a week for 2 weeks. Courses
repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Patients undergo tumor tissue and blood sample collection periodically for correlative
laboratory studies. Samples are assessed for p53 status and S100B, p53, and p21 expression by
immunohistochemistry, polymerase chain reaction, western blotting, luminescence assay, and
ELISA.
After completion of study treatment, patients are followed for 30 days.
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