This study is NOT currently recruiting participants.
Number
16-C-0097
Sponsoring Institute
National Cancer Institute (NCI)
Recruitment Detail
Type: Completed Study; data analyses ongoing Gender: Male & Female Min Age: 2 Years Max Age: 21 Years
Referral Letter Required
No
Population Exclusion(s)
Pregnant Women
Keywords
DIPG; Histone Deacetylase Activity; Pontine Malignancies; Pan-HDAC Inhibitor
Recruitment Keyword(s)
None
Condition(s)
Brain Stem Neoplasms; Pontine Neoplasms; Neoplasms, Pontine; Pontine Tumors
Investigational Drug(s)
Panobinostat
Investigational Device(s)
Intervention(s)
Drug: Panobinostat (3 weeks on, 1 week off) Drug: Panobinostat (every other week)
Supporting Site
National Cancer Institute
Diffuse intrinsic pontine gliomas (DIPGs) are brain tumors. They mostly affect children. They are serious and difficult to treat. There is no known cure. Researchers want to see if a drug approved to treat adults with other kinds of cancer can prevent growth of tumor cells in children with DIPG.
Objective:
To test the safety of a called panobinostat in children. This drug has not yet been studied in children.
Eligibility:
People ages 2 years but less than 22 years of age with DIPG.
Design:
-Participants will be screened with tests that are part of usual cancer care to see if they are eligible to participate in the study.
-All participants enrolled on the study will take panobinostat capsules by mouth every other day, 3 times per week, for 3 weeks, followed by one week of rest. These 4 weeks equal one course of treatment.
-Participants will take the study drug for up to 26 courses.
-Participants will keep a medicine diary.
-During the study, participants will have
--Medical history, physical exam, and blood and urine tests. They will have them weekly in course 1, then once per course.
--During the first week of treatment (on the first and third days), blood will be collected 8 times for research testing, then once per course.
--Neurologic exams, once per course.
--EKG to measure heart electrical activity, once or twice for courses 1-4
--Images taken of their beating heart, twice in the study
--A spinal MRI, brain MRI, and/or brain MRI with diffusion, every few courses.
-When they finish taking the study drug, participants will repeat most of the study tests.
-They will have follow-up for 3 years. After finishing the study drug, participants will continue to be watched for side effects and followed for three years. This will include MRIs and at least 1 office visit. There may be other office visits or phone updates as the study doctor decides.
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ELIGIBILITY CRITERIA: -Patients >= 2 years and < 22 years of age at the time of enrollment -Ability to swallow capsules whole. -Patients must have received a minimum, 54 Gy focal irradiation administered over approximately 42 days, prior to enrollment -Stratum 1 --Patients with progressive DIPG --Patients must have had their last fraction of: Craniospinal irradiation or radiation to >= 50% of pelvis > 3 months prior to enrollment. Focal irradiation to the primary site > 42 days prior to enrollment Local palliative irradiation other than previously irradiated primary site (small port) >= 14 days -Stratum 2 --Patients with DIPG or H3K27M+ Thalamic DMG who have not yet progressed by clinical or radiographic criteria. --Patients must not have received any other prior therapy for treatment of their CNS malignancy besides standard radiation therapy. --Patients must have had their last fraction of focal irradiation to the primary site > 14 days prior to enrollment. --Patients must not have received local palliative irradiation or craniospinal irradiation.
-Patients >= 2 years and < 22 years of age at the time of enrollment
-Ability to swallow capsules whole.
-Patients must have received a minimum, 54 Gy focal irradiation administered over approximately 42 days, prior to enrollment
-Stratum 1
--Patients with progressive DIPG
--Patients must have had their last fraction of:
Craniospinal irradiation or radiation to >= 50% of pelvis > 3 months prior to enrollment.
Focal irradiation to the primary site > 42 days prior to enrollment
Local palliative irradiation other than previously irradiated primary site (small port) >= 14 days
-Stratum 2
--Patients with DIPG or H3K27M+ Thalamic DMG who have not yet progressed by clinical or radiographic criteria.
--Patients must not have received any other prior therapy for treatment of their CNS malignancy besides standard radiation therapy.
--Patients must have had their last fraction of focal irradiation to the primary site > 14 days prior to enrollment.
--Patients must not have received local palliative irradiation or craniospinal irradiation.
Principal Investigator
Referral Contact
For more information: