Pilot Study of Cabozantinib for Recurrent or Progressive High-Grade Glioma in Children
Investigational Medication Safety in Children with Brain Tumors
Brief description of study.
The purpose of this study is to find out if the drug, Cabozantinib, is safe and tolerable in pediatric patients with refractory and/or recurrent high grade gliomas (HGG) who have previously received radiation therapy. We are also looking to see if the drug has an effect on the rate at which the tumor grows at 6 months.
Detailed description of study
The purpose of this study is to test the safety, tolerability and efficacy of carbozantinib in refractory and/or recurrent pediatric high-grade gliomas in children who have previously received radiation therapy.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: high-grade glioma,glioma,brain tumor,brain cancer,tumor,cancer,oncology,pediatric,riley,kid,kids,child,children,teen,teens,teenager,teenagers,youth,adolescent,childhood
-
Age: 2 years - 21 years
-
Gender: All
Inclusion Criteria
Diagnosed with relapsed or refractory high grade glioma (HGG) defined as histologically confirmed WHO grade III or WHO grade IV glioma
Must have histologic verification of malignancy at original diagnosis or relapse
Metastatic disease to the spine is eligible
Patients may be in first, second, or third relapse
Subjects with intrinsic brain stem gliomas may be eligible if histologically confirmed
Patients must have measurable disease
Patient's current disease state must be one for which there is no known curative therapy or therapy proven to prolong survival with an acceptable quality of life
Must have a reasonable life expectancy of at least 2 months
Patients must have fully recovered from the acute toxic effects of all prior anti-cancer chemotherapy
Adequate bone marrow function
Adequate renal function
Adequate liver function
Adequate coagulation status
Adequate pancreatic function
Adequate blood pressure control
Adequate cardiac function
Archival tumor tissue slides must be sent or available
Exclusion Criteria
Pregnant or breastfeeding
Patients receiving corticosteroids who have not been on a stable or decreasing dose of corticosteroid for at least 7 days prior to enrollment
Patients who are currently receiving another investigational drug
Patients who are currently receiving other anti-cancer agents
Patients must not be receiving any of the following CYP3A4 inducers or inhibitors: erythromycin, clarithromycin, ketoconazole, azithromycin, itraconazole, grapefruit juice or St. John's wort
Patients who are receiving systemic therapeutic anticoagulation
Patients must not have received enzyme-inducing anticonvulsants within 14 days prior to enrollment
Patients who are receiving drugs that prolong QTc
Patients must be able to swallow intact tablets
Patient with active bleeding
Patients with evidence of an acute intracranial or intratumoral hemorrhage on CT or MRI
Major surgery within 12 weeks before the first dose of study treatment
Patients on antihypertensive therapy for control of blood pressure at the time of enrollment
Patients with any medical or surgical conditions that would interfere with gastrointestinal absorption of this oral agent
Patient who have an uncontrolled infection
Patient who have received a prior solid organ transplantation
Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study
Subjects who have received cabozantinib or have an allergy to cabozantinib
Subjects who have not received radiation therapy as part of their prior treatment
This study investigates the safety and effects of an investigational medication in children with high-grade gliomas, a type of brain tumor that is difficult to treat. High-grade gliomas are classified as WHO grade III or IV tumors, which are aggressive and fast-growing. The study focuses on pediatric patients who have already undergone radiation therapy and are experiencing tumor recurrence or persistence.
Participants in this study will receive either the investigational medication or a placebo, which is an inactive substance that looks like the investigational medicine but does not contain any medicine. The study will assess how well the investigational medication is tolerated and whether it affects the tumor's growth rate after 6 months.
- Who can participate: Children with relapsed or refractory high-grade glioma, who have had radiation therapy, can participate. They need measurable disease, good organ function, and cannot be pregnant or breastfeeding.
- Study details: Participants will take the investigational medication or a placebo. An inactive substance that looks like the investigational medicine but does not contain any medicine. They must be able to swallow tablets and will need to provide tumor tissue samples for analysis.
Find a site
,
Send a message
Enter your contact details to connect with study team
