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

Primary Purpose

Glioma, Brain Neoplasms, Brain Metastasis

Status
Terminated
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Vardenafil
Carboplatin
Sponsored by
Cedars-Sinai Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glioma focused on measuring Malignant Glioma, Brain Neoplasms, Malignant, Brain metastasis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cedars-Sinai Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Vardenafil + Carboplatin

Carboplatin Alone

Arm Description

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

Carboplatin (Paraplatin®) 100 mg IV administered over 30 minutes at the start of craniotomy

Outcomes

Primary Outcome Measures

Concentration of intratumoral carboplatin in tumor tissue and serum samples

Secondary Outcome Measures

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

Full Information

First Posted
October 29, 2014
Last Updated
September 8, 2017
Sponsor
Cedars-Sinai Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02279992
Brief Title
Pilot Study of Vardenafil and Carboplatin in Patients With Gliomas and Brain Metastases
Acronym
LevitraCarbo
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 Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Terminated
Why Stopped
Unable to accrue to the study. Original PI no longer with the institute.
Study Start Date
March 27, 2012 (Actual)
Primary Completion Date
October 13, 2013 (Actual)
Study Completion Date
February 11, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cedars-Sinai Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glioma, Brain Neoplasms, Brain Metastasis
Keywords
Malignant Glioma, Brain Neoplasms, Malignant, Brain metastasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vardenafil + Carboplatin
Arm Type
Experimental
Arm Description
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
Arm Title
Carboplatin Alone
Arm Type
Active Comparator
Arm Description
Carboplatin (Paraplatin®) 100 mg IV administered over 30 minutes at the start of craniotomy
Intervention Type
Drug
Intervention Name(s)
Vardenafil
Other Intervention Name(s)
Levitra®, Phospodiesterase-V Inhibitor
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Other Intervention Name(s)
Paraplatin®
Primary Outcome Measure Information:
Title
Concentration of intratumoral carboplatin in tumor tissue and serum samples
Time Frame
At the time of tumor resection
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Surasak Phuphanich, MD
Organizational Affiliation
Cedars-Sinai Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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