Glioma Clinical Trial
Official title:
CSMC IIT: Pilot Study of Phosphodiesterase-V Inhibition to Increase Intratumoral Concentration of Carboplatin in Patients With Recurrent High Grade Gliomas and Brain Metastases
This is a randomized pilot study to investigate the ability of a phosphodiesterase-V inhibitor (vardenafil) to increase the concentration of systemically delivered chemotherapy, carboplatin, in patients with recurrent malignant gliomas or metastatic brain cancer. This study will also determine the toxicity and tolerability of a phosphodiesterase-V inhibitor (vardenafil) in combination with intravenous carboplatin for patients with recurrent malignant gliomas or metastatic brain cancer.
Twenty patients (10 pts with recurrent malignant glioma and 10 pts with metastatic brain
tumor) will be randomly assigned to receive either a phosphodiesterase-V inhibitor
(vardenafil) followed by carboplatin or carboplatin alone. All patients will have tumor
resection performed from 2 to 6 hours after administration of carboplatin. Using high
performance liquid chromatographic (HPLC) or ELISA methodology, carboplatin levels will be
determined from both serum and resected tumor tissue. Patients will be followed for four
weeks after craniotomy for toxicity associated with the administration of carboplatin and a
phosphodiesterase-V inhibitor plus carboplatin.
These data will provide quantitative measures of intratumoral carboplatin levels with and
without alteration of blood/tumor barrier (BTB) permeability with vardenafil.
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