Pilot Study of Vardenafil and Carboplatin in Patients With Gliomas and Brain Metastases
Glioma - Brain Neoplasms - Brain Metastasis
Conditions: official terms
Brain Neoplasms - Glioma - Neoplasm Metastasis
Conditions: Keywords
Malignant Glioma, Brain Neoplasms, Malignant, Brain metastasis
Study Type
Study Phase
Phase 0
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Name: Vardenafil Type: Drug
Name: Carboplatin Type: Drug
Overall Status
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- Patients with recurrent malignant glioma or metastatic brain cancer requiring craniotomy for gross total resection, subtotal resection or biopsy

- Previously histopathologically proven glioma or radiographic appearance of metastatic lesion with a primary neoplasm that is known to metastasize to the brain

- Patients must have a Karnofsky performance status ≥ 60% (i.e. the patient must be able to care for himself/herself with occasional help from others)

- Patients must have normal hematologic, renal and liver function (i.e. Hemoglobin >10 gm/dl, Absolute neutrophil count ≥ 1500/mm3, Platelets ≥ 100,000/mm3, creatinine ≤ 1.5 mg/dl or Cr Clearance ≥ 60 mL/min, total bilirubin ≤ 1.5 mg/dl, transaminases ≤ 4 times above the upper limits of the institutional normal.

- Patients must be able to provide written informed consent

Exclusion Criteria:

- Patients with serious concurrent infection or medical illness, which would jeopardize the ability of the patient to receive the treatment outlined in this protocol with reasonable safety

- Patients who are pregnant or breast-feeding

- Patients receiving concurrent therapy for their tumor (i.e. chemotherapeutics or investigational agents)

- Allergy to 5HT-(3) receptor antagonist including tropisetron, ondansetron

- Patients on enzyme-inducing anticonvulsants (Dilantin, Tegretol, Phenobarbital)

- Patients with unstable angina or serious cardiovascular disease

- Known HIV positivity or AIDS-related illness

- History of allergic reaction to platinum compounds or mannitol

- Medical conditions requiring the use of oral nitrates

- Patients on alpha-1 adrenergic blockers
Cedars-Sinai Medical Center
Los Angeles, California, United States
Status: Recruiting
Contact: Surasak Phuphanich, MD - 310-423-7900 - Surasak.Phuphanich@cshs.org
Start Date
May 2011
Completion Date
December 2018
Cedars-Sinai Medical Center
Cedars-Sinai Medical Center
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page