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GlioblastomaPhase 2GKSNCT01011231

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

A Phase 2 study testing Gamma Knife Radiosurgery in people with Glioblastoma, run by University of California, San Francisco at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Glioblastoma
What is being tested?
Gamma Knife Radiosurgery
Type of treatment
Surgery or procedure
How many people
1 participants
Where
1 siteUnited States
Study dates
Dec 2009to Apr 2011
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 15Show fewer
  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • UCSF Department of Neurosurgery

    San Francisco, California, 94143

Other trials in United States

About this study

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

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.

Read the detailed description

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

Conditions
Glioblastoma
Being tested
Gamma Knife Radiosurgery
Keywords
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
Medical subject headings
Glioblastoma, Glioma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Gamma Knife RadiosurgeryProcedure or surgery

    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)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 6 months

Secondary outcomes (3)

  1. 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

    Measured: 1 year

  2. To further assess the safety of GKS in patients with recurrent glioblastoma

    Measured: 1 year

  3. 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.

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Nov 2009 (estimated)
  2. Study startDec 2009
  3. Primary completionApr 2011
  4. Study completionApr 2011

Why it stopped: low accrual

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
1 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01011231
Sponsor's protocol ID
09103
Acronym
GKS
Status last verified
May 2013
First submitted
4 Nov 2009
Last updated
6 May 2013
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Gamma Knife Radiosurgery in people with Glioblastoma, run by University of California, San Francisco at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 6 May 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: low accrual). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary 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. (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01011231.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2013.

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