Dose Escalation Trial of Re-irradiation in Good Prognosis Recurrent Glioblastoma (NCT02709226) | Clinical Trial Compass
CompletedPhase 1
Dose Escalation Trial of Re-irradiation in Good Prognosis Recurrent Glioblastoma
United States17 participantsStarted 2016-06-15
Plain-language summary
Background:
A glioblastoma is a tumor in the brain. It is treated with surgery, chemotherapy and radiation therapy. However, most people s tumors come back after therapy. When the tumor grows back, surgery or chemotherapy may not be possible or may no longer work. Repeat radiation therapy or re-irradiation, is an option for treating these tumors when they regrow.
Objective:
To find out the safety and highest tolerated dose of re-irradiation for people who have recurrent glioblastoma.
Eligibility:
People ages 18 50 who have glioblastoma that has been treated with radiation but has regrown.
Design:
Participants will be screened with:
Medical history
Physical exam
MRI of the brain: They will lie in a machine that takes pictures of the brain.
Participants will have baseline tests before they start therapy. These will include:
Blood tests
Neuropsychological tests: These test things like memory, attention, and thinking.
Quality of life questionnaire
Eye and hearing tests
Participants will get a CT of the brain prior to radiation start in order to plan the radiation treatment. Once the plan is completed, they will receive radiation once a day Monday Friday for a total of 10 17 treatments. They will lie on their back for about 10 minutes while they get the treatment.
Participants will be monitored for side effects.
After they finish treatment, participants will have visits 1, 2, and 3 months later. Then they will have them every 2 months for 3 years. These will include:
Medical history
Physical exam
Blood tests
MRI of the brain.
Quality of life questionnaire
Neuropsychological tests (at some visits)
After 3 years, participants will be contacted by phone each month.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Histological diagnosis
✓. Patients must be age greater than or equal to 18.
✓. Patients should have a KPS greater than or equal to 70%
✓. Prior standard radiation therapy to a dose ranging from 50 to 60 Gy at 1.8 to 2 Gy per fraction.
✓. Patients must be more than or equal to 14 days from previous cytotoxic treatment.
✓. Concurrent therapy
✓. Ability of subject or Legally Authorized Representative (LAR) to understand and the willingness to sign a written informed consent document.
✓. 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
What they're measuring
1
To determine maximum tolerated re-irradiation dose (MTD).
Timeframe: 1 month after completion of re-irradiation
. Prior therapy \< than 2 weeks since surgical re-resection or biopsy
✕. Pregnant or breast feeding females are excluded due to potential mutagenic effects on the developing fetus or newborn
✕. Preexisting grade 3 or 4 nervous system disorder as per CTCAE Version 4.0
✕. 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.
✕. 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.
✕. Patients with preexisting known or suspected radiation sensitivity syndromes will be excluded due to potential confounding effect on outcome.