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

This study has been terminated.
(Unable to accrue to the study. Original PI no longer with the institute.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT02279992
First Posted: October 31, 2014
Last Update Posted: September 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Cedars-Sinai Medical Center
  Purpose
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.

Condition Intervention Phase
Glioma Brain Neoplasms Brain Metastasis Drug: Vardenafil Drug: Carboplatin Early Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Cedars-Sinai Medical Center:

Primary Outcome Measures:
  • Concentration of intratumoral carboplatin in tumor tissue and serum samples [ Time Frame: At the time of tumor resection ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 7
Actual Study Start Date: March 27, 2012
Study Completion Date: February 11, 2016
Primary Completion Date: October 13, 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vardenafil + Carboplatin
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
Other Names:
  • Levitra®
  • Phospodiesterase-V Inhibitor
Drug: Carboplatin
Other Name: Paraplatin®
Active Comparator: Carboplatin Alone
Carboplatin (Paraplatin®) 100 mg IV administered over 30 minutes at the start of craniotomy
Drug: Carboplatin
Other Name: Paraplatin®

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02279992


Locations
United States, California
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Sponsors and Collaborators
Cedars-Sinai Medical Center
Investigators
Principal Investigator: Surasak Phuphanich, MD Cedars-Sinai Medical Center
  More Information

Responsible Party: Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT02279992     History of Changes
Other Study ID Numbers: CSMC IIT: Levitra Carboplatin
Pro00017009 ( Other Identifier: Cedars-Sinai Medical Center )
First Submitted: October 29, 2014
First Posted: October 31, 2014
Last Update Posted: September 11, 2017
Last Verified: September 2017

Keywords provided by Cedars-Sinai Medical Center:
Malignant Glioma
Brain Neoplasms, Malignant
Brain metastasis

Additional relevant MeSH terms:
Neoplasm Metastasis
Brain Neoplasms
Brain Diseases
Neoplasms, Second Primary
Glioma
Neoplastic Processes
Neoplasms
Pathologic Processes
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Central Nervous System Diseases
Nervous System Diseases
Carboplatin
Vardenafil Dihydrochloride
Antineoplastic Agents
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents