Study of Gamma-Knife Radiosurgery Using Magnetic Resonance Imaging (MRI) Spectroscopy for Recurrent Glioma

Stopped early · Phase 2

Conditions studied: Glioblastoma

In brief

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.

Key facts

Study ID

NCT01011231

Run by

University of California, San Francisco

People needed

1

Starts

2009-12-01

Expected to finish

2011-04-01

Last updated by the study team

2013-05-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed glioblastoma, gliosarcoma, anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic oligoastrocytoma, malignant glioma not otherwise specified, low-grade astrocytoma, low-grade oligodendroglioma, low-grade oligoastrocytoma, or low-grade glioma not otherwise specified.
• Prior first-line treatment with surgery or biopsy followed by fractionated radiotherapy with concurrent temozolomide-containing chemotherapy is required for malignant (grade III or IV) glioma patients. Additional prior chemotherapy is allowed, without limitation on number of recurrences. In patients with low-grade tumors, neither prior radiotherapy nor prior chemotherapy is required.
• An interval of > 2 months since completion of fractionated radiotherapy.
• Age > 18 years
• Life expectancy of at least 8 weeks.
• Karnofsky Performance Status score (KPS) of ≥ 60
• Documented recurrent disease: Recurrent disease is defined either as histological confirmation of tumor, as an increase in tumor size of at least 25% based upon serial MR images, or as development of a new site of disease.
• Tumor size will be calculated using the sum of the largest cross-sectional perpendicular diameters of contrast-enhancing tumor for high-grade tumors, the sum of the largest cross-sectional perpendicular diameters of FLAIR abnormality for low-grade tumors, or as worsened spectroscopic characteristics for any tumor type (development of ≥ 2 new voxels with CNI ≥ 3, or ≥ 25% increase in the sum of the CNI ratios within a group of previously abnormal voxels [where abnormal is defined as CNI ≥ 3]).
• Disease must be evaluable, but does not need to be measurable.
• The target site for GKS does not need to be located in a previously-irradiated area.
• Eligibility for gamma-knife radiosurgery: The decision to treat with gamma-knife radiosurgery will be made by a consensus of the radiation oncology, neurosurgery and neuro-oncology co-chairs or their alternates at the weekly Brain Tumor or Gamma-Knife Tumor Conferences. The MRS defined target volume must be ≤ 15 cc. and not involving eloquent brain (speech/language cortex, motor/sensory cortex, basal ganglia, brainstem, or corpus callosum 2) on an MRI done within 14 days of the planned GKS procedure.
• BUN < 25 and Cr < 1.7
• Negative pregnancy test at the time of GKS in any patient who could be pregnant.
• Willingness to forego additional therapy until evidence of disease progression.
• Signed and witnessed informed consent and signed authorization for the release of their protected health information.

You may not qualify if…

• MRS defined tumor volume greater than 15 cc.
• MRS defined tumor volume involving eloquent brain (speech/language cortex, motor/sensory cortex, basal ganglia, brainstem, or corpus callosum).
• Concurrent treatment with chemotherapy.
• Active infectious process requiring IV antibiotics.
• History of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix), unless in complete remission and off of all therapy for that disease for a minimum of three years.
• Other major medical illness judged by the investigator to preclude prolonged follow-up.
• Any condition that compromises compliance with the objectives and procedures of this protocol, as judged by the principal investigator.

Where it is running

• UCSF Department of Neurosurgery — San Francisco, California, United States

Full record on ClinicalTrials.gov

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