Clinical Trials Directory

Trials / Terminated

TerminatedNCT02279992

Pilot Study of Vardenafil and Carboplatin in Patients With Gliomas and Brain Metastases

CSMC IIT: Pilot Study of Phosphodiesterase-V Inhibition to Increase Intratumoral Concentration of Carboplatin in Patients With Recurrent High Grade Gliomas and Brain Metastases

Status
Terminated
Phase
EARLY_Phase 1
Study type
Interventional
Enrollment
7 (actual)
Sponsor
Cedars-Sinai Medical Center · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

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.

Detailed description

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.

Conditions

Interventions

TypeNameDescription
DRUGVardenafil
DRUGCarboplatin

Timeline

Start date
2012-03-27
Primary completion
2013-10-13
Completion
2016-02-11
First posted
2014-10-31
Last updated
2017-09-11

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT02279992. Inclusion in this directory is not an endorsement.