An Early Phase 1 interventional study of Vardenafil and Carboplatin in Glioma, Brain Neoplasms and Brain Metastasis, sponsored by Cedars-Sinai Medical Center. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-09-11.
Sponsored by Cedars-Sinai Medical Center · Early Phase 1, Interventional, and Treatment
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.
3,517 studies on the registry are indexed under Neoplasm Metastasis; 885 are open to participants now.
This study's enrollment of 7 is below the median of 54 across 2,767 interventional studies indexed under Neoplasm Metastasis.
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Exclusion Criteria:
Vardenafil (Levitra®) 20 mg oral administered 1 hour prior to start of craniotomy + Carboplatin (Paraplatin®) 100 mg IV administered over 30 minutes at the start of craniotomy
Drug: Vardenafil · Drug: Carboplatin
Carboplatin (Paraplatin®) 100 mg IV administered over 30 minutes at the start of craniotomy
Drug: Carboplatin
Also known as: Levitra®, Phospodiesterase-V Inhibitor
Also known as: Paraplatin®
Concentration of intratumoral carboplatin in tumor tissue and serum samples
Time frame: At the time of tumor resection
Safety and tolerability of vardenafil in combination with carboplatin using common terminology criteria for adverse events (CTCAE) version 3.0
Time frame: From baseline to 1 month post-resection
This study is terminated, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.
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Cedars-Sinai Medical Center