NCT01378481

High-Dose Vorinostat and Fractionated Stereotactic Body Radiation Therapy in Treating Patients With Recurrent Glioma

High-Dose Vorinostat With Radiation Therapy in the Treatment of Recurrent Glioma

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is being done to determine if an investigational cancer treatment called vorinostat combined with fractionated stereotactic radiation therapy (FSRT) is effective in treating recurrent high grade gliomas. The main goal of this research study is to determine the highest dose of vorinostat that can be given to patients with recurrent tumors. The study will also determine the potential side effects and safety of these treatment combinations. Vorinostat is a small molecule inhibitor of histone deacetylase (HDAC). HDAC inhibitors help unravel the deoxyribonucleic acid (DNA) of the cancer cells and make them more susceptible to the treatment with radiation.

Detailed description

PRIMARY OBJECTIVES: I. To determine the phase II dose when intermittent short-course vorinostat is combined with fractionated radiation therapy in recurrent high-grade glioma. SECONDARY OBJECTIVES: I. Define the pharmacokinetics of vorinostat entry into the cerebrospinal fluid (CSF) and demonstrate that vorinostat influences glioma biology. OUTLINE: This is a dose-escalation study of vorinostat. Patients receive high-dose vorinostat orally (PO) at 48, 27, and 3 hours prior to surgery. Beginning 2-6 weeks later, patients receive vorinostat PO once daily (QD) on days 1-3 in weeks 1-2and undergo fractionated stereotactic body radiation therapy on days 1-5 in weeks 1-2. Treatment continues in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 30 days and then every 3 months for 2 years.

Conditions

• Adult Anaplastic Astrocytoma
• Adult Anaplastic Oligodendroglioma
• Adult Giant Cell Glioblastoma
• Adult Glioblastoma
• Adult Gliosarcoma
• Adult Mixed Glioma
• Recurrent Adult Brain Neoplasm

Interventions

Type	Name	Description
DRUG	Vorinostat	Given PO
RADIATION	Stereotactic Radiosurgery	Undergo fractionated stereotactic radiation therapy
OTHER	Laboratory Biomarker Analysis	Correlative studies
OTHER	Pharmacological Study	Correlative studies
PROCEDURE	Therapeutic Conventional Surgery	Undergo neurosurgery

Timeline

• Start date: 2012-06-01
• Primary completion: 2013-08-01
• Completion: 2013-08-01
• First posted: 2011-06-22
• Last updated: 2014-12-23

Locations

1 site across 1 country: United States