Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
For general information about clinical research, read Learn About Studies.
Eligibility Criteria
- * Age between 5 and 21 years, inclusive
- * Patient diagnosed with DIPG
- * At least 4-week and not greater than 12 weeks from completion of radiation therapy
- * Post-radiation imaging does not show evidence of necrosis/ hemorrhage or other features that contraindicate MRgFUS
- * If brain surgery occurred, at least 14 days passed since last brain surgery and the patient is fully recovered and neurologically stable
- * If on steroids, stable or decreasing dose for at least 7 days prior to study entry
- * Stable or improving neurologic status for 7 days prior to study entry
- * Able and willing to give consent and/or assent or have a legal guardian who is able and willing to do so
- * Able to attend all study visits and with life expectancy of at least 6 months
- * Tumor not visible on any pre-therapy or post-radiation imaging
- * Previous participation in other chemotherapy, molecularly targeted therapy, or immunotherapy treatment-related phase 1 or 2 trials
- * Symptoms and signs of increased intracranial pressure
- * Subject with metastatic disease
- * Subject with ventricular peritoneal shunt
- * Subject receiving bevacizumab (Avastin) therapy or increasing doses of steroids
- * Anti-coagulant therapy, or medications known to increase risk of hemorrhage, (e.g., ASA, non-steroidal anti-inflammatory drugs \[NSAIDs\], statins) within washout period prior to treatment
- * History of a bleeding disorder, coagulopathy or with a history of spontaneous tumor hemorrhage.
- * Hypertension per age
- * Cerebral or systemic vasculopathy, including intracranial thrombosis, vascular malformation, cerebral aneurysm, or vasculitis
- * Immunosuppression (corticosteroids to prevent/treat brain edema are permitted).
- * Patients with positive HIV status
- * Active seizure disorder or epilepsy (seizures despite medical treatment) for a minimum of 4 weeks prior to first cycle/Exablate BBBD procedure captured by history
- * Known sensitivity to gadolinium-based contrast agents
- * Known sensitivity to DEFINITY® ultrasound contrast agent or known hypersensitivity to perflutren microsphere or its components, e.g., polyethylene glycol
- * Contraindication to Doxorubicin
- * Previous treatment with complete cumulative doses of Doxorubicin, daunorubicin, idarubicin, and/or other anthracyclines and anthracenediones
- * Severely impaired renal function with estimated glomerular filtration rate \<2 standard deviations for age
- * Patients that may require trastuzumab during the study
- * Patients that may require inhibitors and inducers of CYP3A4, CYP2D6, and/or P-gp during the study
Ages Eligible for Study
5 Years to 21 Years
Sexes Eligible for Study
ALL
Accepts Healthy Volunteers
No