Your session is about to expire
← Back to Search
Phosphodiesterase Type 5 Inhibitor
Triple Drug Therapy for Brain Tumor
Phase 2
Waitlist Available
Led By Mark G Malkin, MD
Research Sponsored by Virginia Commonwealth University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Pathologically confirmed high-grade glioma (World Health Organization (WHO) grade 3 or 4), with documented computed tomography (CT) or magnetic resonance imaging (MRI) progression or recurrence. Biopsy is also an acceptable method of confirming progression or recurrence. If initial tumor was grade 2 glioma, histological confirmation of high-grade recurrence is required
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from initiation of study treatment to time of best response or off-study (up to 4 years)
Awards & highlights
Study Summary
This trial will test the safety and effectiveness of a combination of three drugs to treat high-grade glioma, a type of brain tumor.
Who is the study for?
This trial is for adults with high-grade glioma, a serious brain tumor that has come back after treatment. They must understand the study and agree to use birth control. Their blood counts and organ functions need to meet specific levels, they should be relatively active (able to care for themselves), and not have used certain drugs recently or have conditions that could interfere with the treatments.Check my eligibility
What is being tested?
The trial tests if combining three drugs—sorafenib (Nexavar®), valproic acid (Depakote®), and sildenafil (Viagra®)—is safe and effective against recurrent high-grade glioma. It checks how well patients tolerate this mix of medications and observes their impact on the brain tumor's progression.See study design
What are the potential side effects?
Possible side effects from these drugs include fatigue, skin reactions, digestive issues like nausea or diarrhea, increased risk of bleeding or bruising due to low platelet count, liver problems indicated by abnormal blood tests, changes in heart rhythm or rate, as well as potential allergic reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My brain tumor has worsened or come back, confirmed by tests or biopsy.
Select...
I can take care of myself and am up and about more than half of my waking hours.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from initiation of study treatment to time of best response or off-study (up to 4 years)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from initiation of study treatment to time of best response or off-study (up to 4 years)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Participants With 6-Month Progression Free Survival (PFS)
Secondary outcome measures
Evaluation of Safety and Toxicity of Sorafenib, Valproic Acid, and Sildenafil
Number of Participants Whose Tumors Express PDGFRa With Best Response of CR Plus Number of Participants Whose Tumor Expresses PDGFRa With Best Response of PR.
Number of Participants Whose Tumors Express PDGFRa With and Without 12-Month PFS.
+3 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (sorafenib tosylate, valproic acid, sildenafil)Experimental Treatment3 Interventions
Sorafenib 400 mg orally twice a day;
Valproic acid (to levels ≥ Lower Level of Normal (LLN) orally twice a day;
Sildenafil 50 mg orally twice a day
A cycle consists of 4 weeks.
*The first 6 patients evaluable for qualifying toxicity assessment will be treated as a safety lead-in; enrollment will be gated (the first 3 evaluable patients must complete 4 weeks of the combination therapy before the next 3 patients start combination treatment on protocol)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
valproic acid
2003
Completed Phase 4
~280
sildenafil citrate
2011
Completed Phase 4
~660
sorafenib tosylate
2005
Completed Phase 2
~920
Find a Location
Who is running the clinical trial?
Virginia Commonwealth UniversityLead Sponsor
697 Previous Clinical Trials
22,884,949 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,657 Previous Clinical Trials
40,933,620 Total Patients Enrolled
Mark G Malkin, MDPrincipal InvestigatorMassey Cancer Center
1 Previous Clinical Trials
12 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- It has been over 12 weeks since I finished radiation therapy of 50 Gray or more.I have seizures and take specific seizure medicines that might not be allowed.My brain tumor has worsened or come back, confirmed by tests or biopsy.Your AST and ALT levels must be within a certain range as determined by the lab test.I do not have conditions that would make antiangiogenic agents unsafe for me.Your kidneys must be working well, with a certain amount of a substance called creatinine in your urine.Your hemoglobin level is at least 8.5 grams per deciliter.Women who could become pregnant must have a negative pregnancy test within 7 days before starting treatment.You need to have a certain number of a type of white blood cell called neutrophils.I have not increased my corticosteroid dose for at least a week.You have a white blood cell count of at least 3,000 per cubic millimeter.Your total bilirubin level is not higher than 1.5 times the upper limit of normal, unless you have Gilbert's disease.I can start taking valproic acid if needed; I may or may not have taken it before.I have previously been treated with bevacizumab or a tyrosine-kinase inhibitor.You have a platelet count of 100,000 or more per cubic millimeter.My brain tumor can be measured or evaluated by specific medical imaging.I can take care of myself and am up and about more than half of my waking hours.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (sorafenib tosylate, valproic acid, sildenafil)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many volunteers are participating in this clinical trial?
"As of now, this clinical trial is no longer recruiting patients. The study was initially posted on 4/11/2013 and was most recently edited on 3/21/2022. However, there are currently 1993 studies actively looking for patients with glioblastoma and 108 studies for sildenafil citrate that are enrolling patients."
Answered by AI
Is it possible to sign up for this test currently?
"The clinical trial mentioned is no longer looking for patients, having last updated the information on their website on March 21st, 2022. However, at the moment, there are 2,101 other trials that are still recruiting patients."
Answered by AI
How is sildenafil citrate commonly used?
"Sildenafil citrate can be used as an intervention to treat acute coryza, mental depression, and hemangiosarcoma."
Answered by AI
What is the official government stance on sildenafil citrate?
"Sildenafil citrate is currently in Phase 2 of clinical trials, meaning that while there is evidence supporting its safety, more research needs to be done to confirm its efficacy."
Answered by AI
Are there other scientific papers that explore sildenafil citrate?
"There are presently 108 different clinical trials underway that involve sildenafil citrate. Out of those, 31 have reached Phase 3 status. The majority of these trials are taking place in Taibei, Taiwan; however, there are 3012 total locations where patients can participate."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger