The purpose of this study is to assess the efficacy, of treating patients with recurrent glioblastoma using Gamma-Knife Radiosurgery (GKS) to target a tumor volume defined by a combination of gadolinium enhancement and magnetic resonance spectroscopy (MRS). This is a single center, Phase II trial. A total of 40 glioblastoma patients will be enrolled into the primary arm of the trial. In addition, a minimum of 10 patients with recurrent anaplastic (grade III) gliomas and a minimum of 10 patients with recurrent low-grade (grade II) gliomas will be enrolled into exploratory arms. The investigators hypothesize that the use of a combination of gadolinium enhancement and elevated Cho:NAA ratio via MRS to determine the treatment target volume for Gamma Knife may be an effective way to treat focally-recurrent glioblastoma.
Study Design: A single-center, single-arm, one-stage phase II clinical trial for patients with recurrent grade IV glioma (glioblastoma), with two additional exploratory arms for patients with recurrent grade II and grade III gliomas. Patient Numbers: A total of 40 patients with recurrent glioblastoma will be enrolled. In addition, a minimum of 10 patients with recurrent grade III (anaplastic) glioma and a minimum of 10 patients with recurrent grade II (low-grade) glioma will be enrolled independently into separate exploratory arms. Summary of Patient Eligibility Criteria Histological confirmation of glioma, grades II - IV; prior first-line treatment with surgery, radiotherapy and chemotherapy for malignant (grades III and IV) gliomas; age \> 18 years; life expectancy \>8 weeks; Karnofsky Performance Status ≥ 60; adequate organ function; signed patient informed consent; willingness to forego additional therapy until evidence of disease progression. End Points Primary: Six-month progression-free survival (PFS-6) Secondary: Median overall survival (mOS), median progression-free survival (mPFS), location of recurrence, symptomatic necrosis rate, reoperation rate, reoperation findings (estimated percentage of viable tumor vs. radiation effect and necrosis), and safety
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1
Patient treatments will be planned with the Gamma Plan software. The dose will be prescribed to the isodose surface which encompasses the target volume within a range of 50-60% based on a local maximum of 100%. Radiosurgery dose will be prescribed based on volume within the prescribed isodose surface (not to exceed 18 cc)
UCSF Department of Neurosurgery
San Francisco, California, United States
To assess the efficacy, as measured by progression-free survival at six months (PFS-6), of treating patients with recurrent glioblastoma using GKS to target a tumor volume defined by a combination of gadolinium enhancement and MRS.
Time frame: 6 months
To describe PFS and OS in pts with recurrent GBM following GKS targeting a tumor volume defined by a combination of gad enhancement and MRS
Time frame: 1 year
To further assess the safety of GKS in patients with recurrent glioblastoma
Time frame: 1 year
To gather initial data regarding the safety and efficacy of treatment of patients with recurrent low-grade or anaplastic glioma with GKS targeting a tumor volume as defined by a combination of gadolinium enhancement and MRS.
Time frame: 1 year
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