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About
By employing a combination of advanced MRI techniques and correlative serum biomarkers of blood brain barrier (BBB) disruption, the investigators plan to develop a powerful, first of its kind clinical algorithm in pediatrics whereby the investigators can measure and identify the window of maximal BBB disruption post MLA to 1) allow for an alternative to surgery in incompletely resected tumors, 2) allow for optimal chemotherapeutic dosing to achieve the greatest benefits and the least systemic side effects and 3) distinguish subsequent tumor progression from long-term MLA treatment effects. Preliminary data in adult imaging studies have shown that the BBB disruption lasts for several weeks following treatment before returning to a low baseline. This pilot therapeutic study will provide preliminary validation in pediatric patients.
Enrollment
Sex
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Volunteers
Inclusion criteria
ARM A
ARM B
Recurrent pediatric brain tumors determined candidates for MLA as determined by the treating neurosurgeon.
Unequivocal evidence of tumor progression by MRI
There must be an interval of at least 12 weeks from the completion of radiotherapy to study registration except if there is unequivocal evidence for tumor recurrence per RANO criteria. When the interval is less than 12 weeks from the completion of radiotherapy, the use of PET scan is allowed to differentiate between evidence of tumor recurrence and pseudoprogression.
Recurrent lesions with dimension and contour that are determined by the treating neurosurgeon to be appropriate for MLA.
Age 3 to ≤ 21
Karnofsky/Lansky performance status ≥ 60%
Adequate cardiac function as determined by a shortening fraction ≥ 27% or left ventricular ejection fraction ≥ 50% by echocardiogram within the past 1 year prior to registration.
Prior anthracycline therapy does not exceed 200 mg/m^2 total cumulative dose.
Adequate bone marrow and hepatic function as defined below (must be within 7 days of MLA):
At the time of registration, patient must have recovered from the toxic effects of prior therapy to no more than grade 1 toxicity.
At the time of registration, patient must be at least 4 weeks from other prior cytotoxic chemotherapy.
Women of childbearing 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 participating in this study, she must inform her treating physician immediately.
Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).
Exclusion criteria
ARM A
ARM B
Primary purpose
Allocation
Interventional model
Masking
6 participants in 2 patient groups
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Central trial contact
Margaret Shatara, M.D.
Data sourced from clinicaltrials.gov
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