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Protocol Details

Phase 1 Trial of Panobinostat in Children with Diffuse Intrinsic Pontine Glioma

This study is NOT currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

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)

None

Intervention(s)

Drug: Panobinostat (3 weeks on, 1 week off)
Drug: Panobinostat (every other week)

Supporting Site

National Cancer Institute

Background:

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

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.


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

John W. Glod, M.D.
National Cancer Institute (NCI)
NIHBC 10 - CRC BG RM 1-3750
10 CENTER DR
BETHESDA MD 20892
(240) 760-6194
john.glod@nih.gov

John W. Glod, M.D.
National Cancer Institute (NCI)
NIHBC 10 - CRC BG RM 1-3750
10 CENTER DR
BETHESDA MD 20892
(240) 760-6194
john.glod@nih.gov

NCI Referral Office
National Institute of Health Clinical Center (CC), 9000 Rockville Pike, Bethesda, Maryland 20892, United States: NCI Clinical Trials Referral Office
1-888-NCI-1937

Clinical Trials Number:

NCT02717455

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