Second radiation blast shows promise for tough brain cancer
NCT ID NCT02709226
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested giving a second round of radiation to people whose glioblastoma (a fast-growing brain tumor) came back after standard treatment. Seventeen adults aged 18 to 50 received daily radiation for 2-3 weeks. The goal was to find the safest highest dose and see how it affected quality of life and thinking skills. The trial is complete and helps guide future treatment options.
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
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
17 people
The number who actually took part.
- Started
-
Jun 2016
- Finished
-
Jul 2023
- Lead sponsor
-
A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
* INCLUSION CRITERIA: 1. Histological diagnosis Previous histologic diagnosis of glioblastoma, transformation to glioblastoma or gliosarcoma established by biopsy or resection prior to enrollment as evident on NIH or outside pathology. 2. Patients must be age greater than or equal to 18. 3. Patients should have a KPS greater than or equal to 70% 4. Prior standard radiation therapy to a dose ranging from 50 to 60 Gy at 1.8 to 2 Gy per fraction. 5. Patients must be more than or equal to 14 days from previous cytotoxic treatment. 6. Concurrent therapy The concurrent use of bevacizumab is allowed if previously initiated for tumor progression or symptomatic management. Prior temozolomide or other cytotoxic chemotherapy is allowed. 7. Ability of subject or Legally Authorized Representative (LAR) to understand and the willingness to sign a written informed consent document. 8. Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. EXCLUSION CRITERIA: 1. Prior therapy \< than 2 weeks since surgical re-resection or biopsy 2. Pregnant or breast feeding females are excluded due to potential mutagenic effects on the developing fetus or newborn 3. Preexisting grade 3 or 4 nervous system disorder as per CTCAE Version 4.0 4. Clinically significant unrelated systemic illness (including but not limited to active life threatening infection, cardiac or neurologic events, current hospital admission for a coexisting comorbid illness), which would make it impossible for the patient to tolerate re-irradiation or systemic chemotherapy or likely to interfere with the results. 5. Patients exhibiting baseline grade 3 or 4 by CTCAE criteria are excluded due to difficulty in assigning these to the study intervention as treatment related DLT. 6. Patients with preexisting known or suspected radiation sensitivity syndromes will be excluded due to potential confounding effect on outcome.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Astrocytoma, grade IV are added.
Genom att skicka in godkänner du våra Användarvillkor
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
-
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- New drug targets Sugar-Coated proteins on cancer cells
- Off-the-Shelf immune cells target solid tumors
- Can a virus injected into brain tumors fight recurrence?
- Could a parasite drug fight childhood brain tumors?
- Can a special MRI reveal hidden brain tumors and guide a stronger radiation strike?
- Can mapping the Blood-Brain barrier in brain tumors unlock new clues?