Symptoms and General Pathology

All Conditions

Neoplasms

Nervous System Diseases

Rare Diseases

Recurrence

Glioma

Glioblastoma

Brain Neoplasms

Disease Attributes

Astrocytoma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Brain Tumor, Adult

Neuroepithelioma

Anticoagulants

All Drugs and Chemicals

Anticonvulsants

Central Nervous System Depressants

Psychotropic Drugs

Vasodilator Agents

Urological Agents

Antineoplastic Agents

Other Dietary Supplements

Citric Acid

Sodium Citrate

Valproic Acid

Sildenafil Citrate

Sorafenib

Protein Kinase Inhibitors

Enzyme Inhibitors

Phosphodiesterase 5 Inhibitors

Phosphodiesterase Inhibitors

Neurotransmitter Agents

Citrate

* 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)

sorafenib tosylate

valproic acid

sildenafil citrate

Andrew Poklepovic, MD

The purpose of this research study is to test the safety, tolerability, and effectiveness of the combination of three drugs, sorafenib (Nexavar®), valproic acid (Depakote®), and sildenafil (Viagra®), when used to treat high-grade glioma, a type of brain tumor.

The study is a single-center, open-label phase 2 study, with an early stopping rule in place for safety. The trial will include patients with recurrent or progressive high-grade glioma.

The trial will be conducted in an adaptive design, with a Simon's mini-max 2-stage design incorporating an interim analysis for efficacy

Sorafenib, Valproic Acid, and Sildenafil in Treating Patients With Recurrent High-Grade Glioma

Phase 2 Study of Sorafenib, Valproic Acid, and Sildenafil in the Treatment of Recurrent High-Grade Glioma

Number of patients evaluable for response, regardless of tumor platelet derived growth factor receptor (PDGFR) status, with 6- month PFS defined as the time from the first day a patient receives study treatment until time of progression per response assessment in neuro-oncology (RANO) or Macdonald criteria or death, whichever occurs first.

Number of patients evaluable for response, with tumors that express PDGFRα, with 6-month PFS defined as the time from the first day a patient receives study treatment until time of progression per RANO or Macdonald criteria or death, whichever occurs first.

Overall response rate (CR+PR), using RANO or Macdonald criteria, in patients evaluable for response regardless of tumor PDGFR status

Overall response rate (CR+PR), using RANO or Macdonald criteria, in patients who are evaluable for response and who have tumors that express PDGFRα.

Number of patients evaluable for response, regardless of tumor PDGFR status, who are alive at 12 months after the first day a patient receives study treatment. Overall Survival (OS) defined as the time from the first day a patient receives study treatment until death by any cause.

Proportion of patients evaluable for response with tumors that express PDGFRα who are alive at 12 months after the first day a patient receives study treatment. On study is defined as the time from the first day a patient receives study treatment until death by any cause.

Number of patients with adverse events, and types of events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).

National Cancer Institute (NCI)

Virginia Commonwealth University

* 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)

sorafenib tosylate: Given by mouth

valproic acid: Given by mouth

sildenafil citrate: Given by mouth

Treatment (Sorafenib Tosylate, Valproic Acid, Sildenafil)

Age, Categorical

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Massey Cancer Center CTO Operations Managers

Number of Participants With 6-Month Progression Free Survival (PFS)

Number of Participants Whose Tumors Express PDGFRa With and Without 6-Month PFS.

Number of Participants With Best Response of CR Plus Number of Participants With Best Response of PR.

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 With 12-Month Progression Free Survival (PFS).

Number of Participants Whose Tumors Express PDGFRa With and Without 12-Month PFS.

Evaluation of Safety and Toxicity of Sorafenib, Valproic Acid, and Sildenafil

Overall Study

Spots Global Cancer Trial Database for Sorafenib, Valproic Acid, and Sildenafil in Treating Patients With Recurrent High-Grade Glioma

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial