Pentamidine in Treating Patients With Relapsed or Refractory Melanoma
Recruitment status was Recruiting
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.
Genetic: gene expression analysis
Genetic: polymerase chain reaction
Genetic: western blotting
Other: immunoenzyme technique
Other: immunohistochemistry staining method
Other: laboratory biomarker analysis
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Treatment of Melanoma With Wild-type p53 and Detectable S100B Using Pentamidine: a Phase II Trial With Correlative Biomarker Endpoints|
- Clinical response [ Designated as safety issue: No ]
- Wild-type p53 and S100B status at baseline [ Designated as safety issue: No ]
- Pre- and post-treatment changes in the concentration of S100B and p21 in tumor biopsy samples [ Designated as safety issue: No ]
- Serial levels of serum S100B [ Designated as safety issue: No ]
|Study Start Date:||July 2008|
|Estimated Primary Completion Date:||July 2010 (Final data collection date for primary outcome measure)|
- 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 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00729807
|United States, Maryland|
|Greenebaum Cancer Center at University of Maryland Medical Center||Recruiting|
|Baltimore, Maryland, United States, 21201|
|Contact: Clinical Trials Office - Greenebaum Cancer Center at Universit 800-888-8823|
|Principal Investigator:||Edward A. Sausville, MD, PhD||University of Maryland Greenebaum Cancer Center|