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Phase II Study of Gamma-Knife Radiosurgery Using Magnetic Resonance Spectroscopy for Target Definition in Patients With Recurrent Glioma


Phase 2
18 Years
N/A
Not Enrolling
Both
Glioblastoma

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Trial Information

Phase II Study of Gamma-Knife Radiosurgery Using Magnetic Resonance Spectroscopy for Target Definition in Patients With Recurrent Glioma


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


Inclusion Criteria:



1. 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.

2. 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.

3. An interval of > 2 months since completion of fractionated radiotherapy.

4. Age > 18 years

5. Life expectancy of at least 8 weeks.

6. Karnofsky Performance Status score (KPS) of ≥ 60

7. 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.

8. 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.

9. BUN < 25 and Cr < 1.7

10. Negative pregnancy test at the time of GKS in any patient who could be pregnant.

11. Willingness to forego additional therapy until evidence of disease progression.

12. Signed and witnessed informed consent and signed authorization for the release of
their protected health information.

Exclusion Criteria:

1. MRS defined tumor volume greater than 15 cc.

2. MRS defined tumor volume involving eloquent brain (speech/language cortex,
motor/sensory cortex, basal ganglia, brainstem, or corpus callosum).

3. Concurrent treatment with chemotherapy.

4. Active infectious process requiring IV antibiotics.

5. 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.

6. Other major medical illness judged by the investigator to preclude prolonged
follow-up.

7. Any condition that compromises compliance with the objectives and procedures of this
protocol, as judged by the principal investigator.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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.

Outcome Time Frame:

6 months

Safety Issue:

No

Principal Investigator

Jennifer Clarke, MD, MPH

Investigator Role:

Principal Investigator

Investigator Affiliation:

UCSF Department of Neurosurgery

Authority:

United States: Institutional Review Board

Study ID:

09103

NCT ID:

NCT01011231

Start Date:

December 2009

Completion Date:

April 2011

Related Keywords:

  • Glioblastoma
  • Gamma Knife radiosurgery
  • recurrent glioma
  • MRI
  • Spectroscopy
  • Recurrent grade IV glioma (glioblastoma), with two additional exploratory arms for patients with recurrent grade II and grade III gliomas
  • Glioblastoma
  • Glioma

Name

Location

UCSF Department of NeurosurgerySan Francisco, California  94143