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Stereotactic Radiosurgery With Nivolumab and Valproate in Patients With Recurrent Glioblastoma

NCT02648633 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2017-05-31

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety and feasibility of the immunotherapeutic agent nivolumab given in combination with gamma knife therapy and valproate in patients with recurrent glioblastoma, a common and lethal type of brain cancer.

Conditions

Interventions

RADIATION

Stereotactic Radiosurgery

Subjects will receive a single large dose of radiation to one or more lesions.

DRUG

Nivolumab

3 mg/kg of nivolumab will be administered through IV infusion every two weeks following stereotactic radiosurgery.

DRUG

Valproate

Subjects will begin regimen of valproate prior to radiosurgery and continue to receive therapy concurrently with nivolumab. Subjects will receive valproate daily with a target serum level of 75-100 μg/ml.

Sponsors & Collaborators

  • University of Virginia

    lead OTHER

Principal Investigators

  • Benjamin Purow, MD · University of Virginia

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-24
Primary Completion
2017-02-21
Completion
2017-02-21

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02648633 on ClinicalTrials.gov