Background:
Glioblastoma (GBM) is a cancer of the brain. Current survival rates for people with GBM
are poor; survival ranges from 5.2 months to 39 months. Most tumors come back within
months or years after treatment, and when they do, they are worse: Overall survival drops
to less than 10 months. No standard treatment exists for people whose GBM has returned
after radiation therapy.
Objective:
To find a safe schedule for using radiation to treat GBM tumors that returned after
initial radiation treatment.
Eligibility:
People aged 18 years and older with grade 4 GBM that returned after initial radiation
treatment.
Design:
Participants will be screened. They will have a physical exam with blood tests. A sample
of tumor tissue may be collected.
Participants will undergo re-irradiation planning: They will wear a plastic mask over
their head during imaging scans. These scans will pinpoint the exact location of the
tumor. This spot will be the target of the radiation treatments.
Participants will undergo radiation treatment 4 times per week. Some people will have
this treatment for 3 weeks, some for 2 weeks, and some for 1 week. Blood tests and other
exams will be repeated at each visit.
Participants will complete questionnaires about their physical and mental health. They
will answer these questions before starting radiation treatment; once a week during
treatment; and at intervals for up to 3 years after treatment ends.
Participants will have follow-up visits 1 month after treatment and then every 2 months
for 6 months. Follow-up clinic visits will continue up to 3 years. Follow-ups by phone or
email will continue an additional 2 years.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06344130.
Locations matching your search criteria
United States
Maryland
Bethesda
National Institutes of Health Clinical CenterStatus: Active
Contact: National Cancer Institute Referral Office
Phone: 888-624-1937
Background:
- Although survival of glioblastoma (GBM) has improved using standard of care
chemoradiation, outcomes are still poor. Most patients will recur within months to
years, in or adjacent to their previous treatment field.
- There is no consensus standard of care for patients with recurrent GBM. Re-resection
is recommended, if possible, to improve symptoms and decrease tumor volume. However,
this treatment option is possible only in a minority of patients, and for these
patients re-irradiation has emerged as a possible treatment.
- Modern radiation therapy (RT) techniques allow delivery of re-irradiation while
minimizing the dose to previously treated organs at risk (OAR) within the radiation
field.
- Data from a recently completed clinical trial at our center (16-C-0081, NCT02709226)
suggests that the Maximum Tolerated Dose (MTD) of re-irradiation in 350 cGy
fractions is 4200 cGy.
Objective:
-To determine the maximum tolerated dosage of daily re-irradiation in participants with
recurrent Grade 4 gliomas
Eligibility:
- A histologic diagnosis of GBM, gliosarcoma, or transformation, from a lower grade to
a grade 4 brain tumor.
- Previous glioma irradiation to curative-intent doses.
- Age >= 18.
- Karnofsky performance scale (KPS) >= 70.
Design:
- This is a single center phase I trial using a '3 + 3' design and a three (3) dose
level hypofractionation schema to enroll a maximum of 21 evaluable participants.
- Prior to radiation therapy, participants will undergo laboratory evaluations,
magnetic resonance imaging (MRI), and a treatment planning computed tomography (CT).
- RT will be administered daily 4 days a week for 1, 2, or 3 weeks in the Radiation
Oncology Branch, NCI, at NIH. Radiation will be delivered on consecutive days, 4
fractions per week via a linear accelerator using 6 megavoltage (MV) photons or
greater.
- Follow-up visits following RT are planned at 1 month, every 2 months for years 1-2,
and every 3 months for year 3. These visits will be stopped earlier in case of
progression. After progression or 3 years of follow-up, participants will be
followed remotely for survival
until 5 years after treatment completion.
Lead OrganizationNational Cancer Institute
Principal InvestigatorPeter Mathen
