Clinical trial · Interventional
Pilot Study of Vardenafil and Carboplatin in Patients With Gliomas and Brain Metastases
CSMC IIT: Pilot Study of Phosphodiesterase-V Inhibition to Increase Intratumoral Concentration of Carboplatin in Patients With Recurrent High Grade Gliomas and Brain Metastases
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Unable to accrue to the study. Original PI no longer with the institute.
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Metastasis | — | UNRESOLVED | — |
| Brain Neoplasms | Brain Neoplasm | ONTOLOGY_EXACT | 0.90 |
| Glioma | Glioma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carboplatin | Drug | Carboplatin | ALIAS |
| Vardenafil | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Vardenafil + Carboplatin
- 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
- interventionNames
- Drug: Vardenafil
- Drug: Carboplatin
- type
- ACTIVE_COMPARATOR
- label
- Carboplatin Alone
- description
- Carboplatin (Paraplatin®) 100 mg IV administered over 30 minutes at the start of craniotomy
- interventionNames
- Drug: Carboplatin
Primary outcomes (1)
- measure
- Concentration of intratumoral carboplatin in tumor tissue and serum samples
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available