Sorafenib Tosylate, Valproic Acid, and Sildenafil Citrate in Treating Patients With Recurrent High-Grade Glioma
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|ClinicalTrials.gov Identifier: NCT01817751|
Recruitment Status : Active, not recruiting
First Posted : March 25, 2013
Last Update Posted : July 16, 2020
|Condition or disease||Intervention/treatment||Phase|
|Glioblastoma Recurrent Adult Brain Neoplasm Malignant Glioma WHO Grade III Glioma||Drug: sorafenib tosylate Drug: valproic acid Drug: sildenafil citrate||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||47 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 2 Study of Sorafenib, Valproic Acid, and Sildenafil in the Treatment of Recurrent High-Grade Glioma|
|Actual Study Start Date :||April 11, 2013|
|Estimated Primary Completion Date :||June 30, 2021|
|Estimated Study Completion Date :||June 30, 2022|
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, Nexavar
Drug: valproic acid
Other Name: 2-Propylpentanoic or Propylvaleric Acid, Alti-Valproic, Depakene, Di-n-propylacetic Acid, Ergenyl, Novo-Valproic, VA, Valproate, Valproate Sodium
Drug: sildenafil citrate
Other Name: Viagra
- 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.
- Incidence of adverse events using the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0 [ Time Frame: Up to 30 days following the end of study treatment ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01817751
|United States, Virginia|
|Virginia Commonwealth University/Massey Cancer Center|
|Richmond, Virginia, United States, 23298|
|Principal Investigator:||Mark G Malkin, MD||Massey Cancer Center|