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

Information source: Cedars-Sinai Medical Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Glioma; Brain Neoplasms; Brain Metastasis

Intervention: Vardenafil (Drug); Carboplatin (Drug)

Phase: Phase 0

Status: Recruiting

Sponsored by: Cedars-Sinai Medical Center

Official(s) and/or principal investigator(s):
Surasak Phuphanich, MD, Principal Investigator, Affiliation: Cedars-Sinai Medical Center

Overall contact:
Surasak Phuphanich, MD, Phone: 310-423-7900, Email: Surasak.Phuphanich@cshs.org

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Concentration of intratumoral carboplatin in tumor tissue and serum samples

Secondary outcome: Safety and tolerability of vardenafil in combination with carboplatin using common terminology criteria for adverse events (CTCAE) version 3.0

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): 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

Locations and Contacts

Surasak Phuphanich, MD, Phone: 310-423-7900, Email: Surasak.Phuphanich@cshs.org

Cedars-Sinai Medical Center, Los Angeles, California 90048, United States; Recruiting
Surasak Phuphanich, MD, Phone: 310-423-7900, Email: Surasak.Phuphanich@cshs.org
Cherry Sanchez, RN, Phone: 310-423-6839, Email: Cherry.Sanchez@cshs.org
Additional Information

Starting date: May 2011
Last updated: April 6, 2015

Page last updated: August 23, 2015

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