Sorafenib Tosylate, Valproic Acid, and Sildenafil Citrate in Treating Patients With Recurrent High-Grade Glioma
|Glioblastoma Glioma Recurrent Adult Brain Neoplasm||Drug: sorafenib tosylate Drug: valproic acid Drug: sildenafil citrate||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
|Official Title:||Phase II Study of Sorafenib, Valproic Acid, and Sildenafil in the Treatment of Recurrent High-Grade Glioma|
- PFS [ Time Frame: 6 months ]The Kaplan-Meier method will be used to describe the time to progression and the median time to progression will be estimated, along with its 95% confidence intervals, for the entire population and for PDGFRa expression, respectively. Cox regression analysis will be used to evaluate baseline characteristics and any potential covariates.
- Overall best response rate (complete response + partial response) using RANO or Macdonald criteria. [ Time Frame: Up to 4 years ]Will be estimated for the entire study population and for the PDGFRa expressing high-grade glioma cohort, along with the 95% confidence intervals.
- Overall survival [ Time Frame: From the first day of study treatment until death by any cause, assessed up to 12 months ]The Kaplan-Meier method will be used to describe the time to overall survival and the median time to overall survival will be estimated, and along with its 95% confidence intervals, for the entire population and for PDGFRa expression, respectively. Cox regression analysis will be used to evaluate baseline characteristics and any potential covariates.
|Study Start Date:||April 11, 2013|
|Estimated Study Completion Date:||December 31, 2018|
|Estimated Primary Completion Date:||December 31, 2017 (Final data collection date for primary outcome measure)|
Experimental: Treatment (sorafenib tosylate, valproic acid, sildenafil)
Patients receive sorafenib tosylate PO, valproic acid* PO, and sildenafil citrate PO BID for 4 weeks. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
* NOTE: Patients not receiving antiepileptic therapy begin valproic acid 1 week prior to the first day of sorafenib tosylate and sildenafil citrate.
Drug: sorafenib tosylate
Other Name: pyridinecarboxamide, chloro-trifluoromethylphenyl pyridine-carboxyllic acid methyamide-methylbenzenesulfonate tosylate, NexavarDrug: valproic acid
Other Name: 2-Propylpentanoic or Propylvaleric Acid, Alti-Valproic, Depakene, Di-n-propylacetic Acid, Ergenyl, Novo-Valproic, VA, Valproate, Valproate SodiumDrug: sildenafil citrate
Other Name: Viagra
Please refer to this study by its ClinicalTrials.gov identifier: NCT01817751
|Contact: Mary Beth Tombes, NPemail@example.com|
|Contact: Solid Tumor Investigator-Initiated Trials (SIIT) Teamfirstname.lastname@example.org|
|United States, Virginia|
|Virginia Commonwealth University/Massey Cancer Center||Recruiting|
|Richmond, Virginia, United States, 23298|
|Contact: Mary Beth Tombes, NP 804-628-1357 email@example.com|
|Principal Investigator: Mark Malkin, MD|
|Principal Investigator:||Mark Malkin, MD||Massey Cancer Center|