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

NCT02279992 | Terminated Early Phase 1

• 2 other identifiers: CSMC IIT: Levitra CarboplatinPro00017009
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Glioma; Brain Neoplasms; Brain Metastasis

Keywords

Malignant Glioma; Brain Neoplasms, Malignant; Brain metastasis

Outcome Measures

Primary Outcomes (1)

• Concentration of intratumoral carboplatin in tumor tissue and serum samples

  At the time of tumor resection

Secondary Outcomes (1)

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

  From baseline to 1 month post-resection

Study Arms (2)

Vardenafil + Carboplatin

EXPERIMENTAL

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 Alone

ACTIVE COMPARATOR

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

Drug: Carboplatin

Interventions

Vardenafil DRUG

Also known as: Levitra®, Phospodiesterase-V Inhibitor

Vardenafil + Carboplatin

Carboplatin DRUG

Also known as: Paraplatin®

Carboplatin Alone; Vardenafil + Carboplatin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

MeSH Terms

Conditions

Glioma; Brain Neoplasms

Interventions

Vardenafil Dihydrochloride; Carboplatin

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines; Coordination Complexes; Organic Chemicals

Study Officials

• Surasak Phuphanich, MD

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2014
• First Posted: October 31, 2014
• Study Start: March 27, 2012
• Primary Completion: October 13, 2013
• Study Completion: February 11, 2016
• Last Updated: September 11, 2017

Record last verified: 2017-09

Locations

US (1)