GliomaEarly Phase 1LevitraCarboNCT02279992
Pilot Study of Vardenafil and Carboplatin in Patients With Gliomas and Brain Metastases
A Early Phase 1 study testing Vardenafil and Carboplatin in people with Glioma and Brain Neoplasms, run by Cedars-Sinai Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioma, Brain Neoplasms, Brain Metastasis
- What is being tested?
- Vardenafil and Carboplatin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Mar 2012to 11 Feb 2016
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Cedars-Sinai Medical Center
Los Angeles, California, 90048
About this study
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
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.
Read the 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.
- Conditions
- Glioma, Brain Neoplasms, Brain Metastasis
- Being tested
- Vardenafil, Carboplatin
- Keywords
- Malignant Glioma, Brain Neoplasms, Malignant, Brain metastasis
- Medical subject headings
- Glioma, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VardenafilDrug
Also called Levitra®, Phospodiesterase-V Inhibitor
CarboplatinDrug
Also called Paraplatin®
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Vardenafil; Drug: Carboplatin |
| Carboplatin Alone | Active comparator | Carboplatin (Paraplatin®) 100 mg IV administered over 30 minutes at the start of craniotomy Receives: Drug: Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of intratumoral carboplatin in tumor tissue and serum samples
Measured: 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
Measured: From baseline to 1 month post-resection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2014 (estimated)
- Study start27 Mar 2012
- Primary completion13 Oct 2013
- Study completion11 Feb 2016
Why it stopped: Unable to accrue to the study. Original PI no longer with the institute.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GliomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Surasak Phuphanich, MD, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02279992
- Sponsor's protocol ID
- CSMC IIT: Levitra Carboplatin
- Other IDs
- Pro00017009
- Acronym
- LevitraCarbo
- Status last verified
- Sep 2017
- First submitted
- 29 Oct 2014
- Last updated
- 11 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02279992
- Acronym / sponsor ID
- LevitraCarbo / CSMC IIT: Levitra Carboplatin
- Conditions
- Glioma, Brain Neoplasms, Brain Metastasis
- Keywords
- Malignant Glioma, Brain Neoplasms, Malignant, Brain metastasis
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to accrue to the study. Original PI no longer with the institute.
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Study start
- 27 Mar 2012 (actual)
- Primary completion
- 13 Oct 2013 (actual)
- Study completion
- 11 Feb 2016 (actual)
- First posted
- 31 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vardenafil + Carboplatin | Experimental | Drug: Vardenafil, Drug: CarboplatinVardenafil (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 Alone | Active comparator | Drug: CarboplatinCarboplatin (Paraplatin®) 100 mg IV administered over 30 minutes at the start of craniotomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VardenafilAlso: Levitra®, Phospodiesterase-V Inhibitor | Drug | Vardenafil + Carboplatin |
| CarboplatinAlso: Paraplatin® | Drug | Carboplatin Alone, Vardenafil + Carboplatin |
Primary outcome
Concentration of intratumoral carboplatin in tumor tissue and serum samples
Time frame: At the time of tumor resection
1 secondary outcome
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
Results and safety
The study was stopped early (reason given: Unable to accrue to the study. Original PI no longer with the institute.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Surasak Phuphanich, MD principal investigator
Cedars-Sinai Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Vardenafil and Carboplatin in people with Glioma and Brain Neoplasms, run by Cedars-Sinai Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Unable to accrue to the study. Original PI no longer with the institute.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentration of intratumoral carboplatin in tumor tissue and serum samples (time frame: At the time of tumor resection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2017.