Stereotactic Radiosurgery With Nivolumab and Valproate in Patients With Recurrent Glioblastoma

Part of paid clinical trials in Charlottesville, Virginia.

Sponsor
University of Virginia
Study ID
NCT02648633
Phase
PHASE1
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Stereotactic Radiosurgery — RADIATION
    Subjects will receive a single large dose of radiation to one or more lesions.
  • Nivolumab — DRUG
    3 mg/kg of nivolumab will be administered through IV infusion every two weeks following stereotactic radiosurgery.
  • Valproate — DRUG
    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.

Study Details

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.

Key Dates

Start date
May 24, 2016
Status verified
May 2017
Primary completion
Feb 21, 2017
Completion
Feb 21, 2017

Study Design

Enrollment
4 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Nivolumab & Valproate Following G.K.
    Subjects will begin a valproate regimen prior to undergoing stereotactic radiosurgery (gamma knife) on a single lesion. Following the surgery, subjects will receive nivolumab every 2 weeks and daily valproate.

Primary Outcome Measure

Feasibility based on number of subjects who complete 4 doses of nivolumab [ Time Frame: At 3 months following radiosurgery ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of VirginiaCharlottesvilleVirginia22908-

Find similar trials in Charlottesville, VA

By condition
Brain cancer
By specialty
OncologyNeuro-oncology
By research site
University of Virginia· Charlottesville, VA

Related Studies