Phase I/II Study of Reirradiation of Recurrent or Progressive Brainstem Glioma
Radiation Therapy Administration:
If you are found to be eligible to take part in this study, you will be assigned to a dose
level of radiation therapy based on when you join this study. Three (3) dose levels of
radiation therapy will be tested. Three (3) participants will be enrolled at each dose
level. The first group of participants will receive the lowest dose level. Each new group
will be randomly assigned (as in the roll of dice) to one of the dose levels, and the
assignment will also depend on how the previous participants have done. Participants will
not be assigned to one of the higher 2 of the 3 dose levels unless the lower dose level is
found to be tolerable. The first and second groups will receive 12 treatments and the third
group will receive 14 treatments (Monday through Friday for about 2½ weeks). Your doctor
will tell you how many treatments you will receive.
You may be given drugs to help prevent side effects. The study staff will tell you about
these drugs, how they will be given, and the possible risks.
About 2-4 days before you start radiation therapy, you will have a simulation. During the
simulation session, a mask will be made of your face and head to keep you still. You will
also have a computed tomography (CT) scan. This process allows the radiation planning to
take place. Sedation by an anesthesiologist (anesthesia doctor) will be used if needed for
young children to allow the radiotherapy to be delivered safely.
One (1) time a week for 3 weeks, and then 1 time a month (30 days +/- 10 days) for 2 months
or unless the disease gets worse:
- Any updates to your medical history will be recorded.
- You will have a physical exam, including a neurological exam.
- Your performance status will be recorded.
- You will fill out the quality-of-life questionnaire.
- You will be asked about any side effects you may have had.
You will have a magnetic resonance imaging (MRI) scan of the brain within 1 month after
joining the study.
Length of Treatment:
You may continue receiving radiation therapy for 12 or 14 treatments. You will no longer be
able to receive radiation therapy if the disease gets worse, if intolerable side effects
occur, or if you are unable to follow study directions.
One (1) month after you finish radiation therapy, at 6-8 weeks, then every 2-3 months after
that from then on, you will have an MRI scan to check the status of the disease. The MRI
scan will include advanced imaging to learn if the tumor has come back or if there is brain
tissue damage from the radiation. With this type of imaging, a temporary infusion line with
a bigger than standard size needle will be inserted to your vein if you do not already have
a power port-a-cath in place. This may take between 20-30 minutes.
This is an investigational study. Radiation therapy in this study is delivered using
FDA-approved and commercially available methods. It is investigational to find the best
dose of radiation therapy to use for repeat radiation therapy.
Up to 30 patients will take part in this study. All will be enrolled at MD Anderson.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Optimal Dose Level Among Three Radiation Therapy (RT) Dose Levels
Optimal dose level among three RT dose levels, defined in terms of the biologically equivalent dose (BED). The BED is given by the formula BED = (Total Dose)*(1 + d/3), denoting d = dose/fraction, with the constant 3 corresponding to brain tissue.
1 month after radiation therapy
Anita Mahajan, MD
UT MD Anderson Cancer Center
United States: Institutional Review Board
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