Brain cancer trial aims to outsmart recurrence by zapping stem cells
NCT ID NCT02177578
First seen Jun 27, 2026 · Last updated Jun 30, 2026 · Updated 2 times
Summary
This study tests whether giving a higher radiation dose to a brain area called the subventricular zone (where stem cells live) can delay glioblastoma from coming back. About 60 adults with newly diagnosed glioblastoma will receive standard radiation and chemo, but half will get extra radiation to that stem cell region. The goal is to see if this approach keeps the tumor under control longer than standard treatment alone.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2014
- Expected to finish
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Aug 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 100 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patient must have newly diagnosed, histologically confirmed GBM. * Patient must have undergone gross total resection, subtotal resection, or biopsy with the extent of resection determined by the treating neurosurgeon, and must begin radiation within 12 weeks of this procedure. * Patients must not have received previous irradiation to the brain. * Patient must be at least 18 years of age since the diagnosis of GBM in patients younger than 18 is rare and accurate evaluation of neurocognitive function would require a different battery of examinations than employed in this study. * ECOG performance status 0-2 (Karnofsky \>60%; see Appendix A). * Patient must be scheduled to receive temozolomide concurrent with and following radiation (temozolomide may be started late due to insurance reasons, insufficient counts, or other reasons). * If a woman is of child-bearing potential, a negative urine or serum pregnancy test must be demonstrated prior to treatment. Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) for the duration of study participation and for up to 12 weeks following the study. Should a women become pregnant or suspect she is pregnant while participating in this study she should inform her treating physician immediately. * Patient must have the ability to understand and the willingness to sign a written informed consent document. * All patients must be informed of the investigational nature of this study and must be given written informed consent in accordance with institutional and federal guidelines. * Radiation therapy must begin within 12 weeks of surgery. Exclusion Criteria: * No prior malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, cervical carcinoma in situ, or other cancer from which the patient has been disease free for at least 2 years. * Patients with uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements will be excluded. * Pregnant and breastfeeding women are excluded. Women of child-bearing potential who are unwilling or unable to use an acceptable method of birth control to avoid pregnancy for the entire study period and up to 12 weeks after the study are excluded. This applies to any woman who has not experienced menarche and who has not undergone successful surgical sterilization or is not postmenopausal (defined as amenorrhea for at least 12 consecutive months). Male subjects must also agree to use effective contraception for the same period as above. * Use of Avastin or another VEG-F inhibitor prior to progression is not permitted.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Sibley Memorial Hospital
Washington D.C., District of Columbia, United States
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Suburban Hospital
Bethesda, Maryland, United States
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The SKCCC at Johns Hopkins
Baltimore, Maryland, 21287, United States
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