Treatment of Melanoma With Wild-type p53 and Detectable S100B Using Pentamidine: a Phase II Trial With Correlative Biomarker Endpoints
- To determine the response rate in patients with relapsed or refractory melanoma that
expresses wild-type p53 and S100B treated with pentamidine.
- To observe the effect of this drug on the expression of S100B and p21 in tumor biopsy
- 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
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,
After completion of study treatment, patients are followed for 30 days.
Masking: Open Label, Primary Purpose: Treatment
Edward A. Sausville, MD, PhD
University of Maryland Greenebaum Cancer Center
|Greenebaum Cancer Center at University of Maryland Medical Center||Baltimore, Maryland 21201|