NCT00729807

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

Treatment of Melanoma With Wild-type p53 and Detectable S100B Using Pentamidine: a Phase II Trial With Correlative Biomarker Endpoints

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: University of Maryland, Baltimore · Academic / Other
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Melanoma (Skin)

Interventions

Type	Name	Description
DRUG	pentamidine

Timeline

• Start date: 2008-07-01
• Primary completion: 2012-08-01
• Completion: 2012-11-01
• First posted: 2008-08-08
• Last updated: 2019-08-16
• Results posted: 2016-10-21

Locations

1 site across 1 country: United States