Clinical Trial Details
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NCT03632317 : A Study of Panobinostat in Combination With Everolimus for Children and Young Adults With Gliomas
PhasePhase 2
AgesMin: 2 Years Max: 30 Years
Inclusion Criteria:

- All patients and/or a legal guardian must sign institutionally approved written
informed consent and assent documents.

- Patient must be greater than 2 years and less than 30 years

- BSA (body surface area) greater than 0.3 m2

- Functional status: Karnofsky > 50% for patients > 16 years of age and Lansky > 50% for
patients < 16 years of age (Karnofsky and Lansky is a scoring system used to quantify
the general well being of cancer patients where 100% represents perfect health and 0%
represents death). Neurologic deficits in patients with CNS tumors must have been
relatively stable for a minimum of 7 days. Patients who are unable to walk because of
paralysis, but who are able to sit in a wheelchair, will be considered ambulatory for
the purpose of assessing the performance score.

- Adequate bone marrow function

- Adequate liver function

- Adequate renal and metabolic function

- Urine protein:creatinine (UPC) ratio of < 1; or a urinalysis that is negative for
protein; or 24-hour urine protein level < 1000 mg/dL

- Patients must have Magnesium > 1.5 mg/dL and potassium > 3.5 mmol/L

- Patients with known seizure disorder must have seizures adequately controlled with
non- enzyme inducing antiepileptic medications

- No increase in steroid dose within the past 7 days.

- STRATUM A: histological confirmation of a newly diagnosed high-grade glioma or DIPG or
STRATUM B: histological confirmation of a recurrent or progressive grade II-IV glioma
(including DIPG) [histology can come from tissue at diagnosis or relapse]

- Primary brain or spine tumor are eligible, including tumors with metastases, multiple

- Patients must have fully recovered from the acute toxic effects of all prior
chemotherapy, immunotherapy, or radiotherapy.

- Myelosuppressive chemotherapy: Must not have received within 3 weeks (6 weeks if prior

- Hematopoietic growth factors: At least 7 days since the completion of therapy with a
growth factor, 14 days for long-acting (e.g. PEG-filgrastim)

- Biologic (anti-neoplastic agent): At least 7 days or 3 half-lives (whichever is
longer) since the completion of therapy with a biologic agent.

- Radiation therapy: Strata A: = 2 weeks and = to 12 weeks must have elapsed from
radiation. Strata B: = 2 weeks must have elapsed from focal radiation.

- Surgery: > 3 weeks from major surgery. If recent craniotomy, adequate wound healing
must be determined by neurosurgical team.

- Autologous Stem Cell Transplant or Rescue: No evidence of active graft vs. host
disease and = 4 weeks must have elapsed.

- H3K27M mutation: Participants must have a mutation in H3.3 K27M or H3.1 K27M as
identified by tumor (FFPE or fresh, diagnosis or relapse tissue, but relapse tissue
preferred) sequencing, or by CLIA-certified immunohistochemistry staining positive for
H3K27M, as defined by review by U of M neuro-pathology.

Exclusion Criteria:

- Patients who are breastfeeding, pregnant or refuse to use an effective form of birth
control are excluded. Abstinence is considered an effective form of birth control.

- Patients with uncontrolled infection are excluded.

- Inability to swallow oral pill (panobinostat does not have liquid formulation).

- Other medications: Patients receiving other anti-neoplastic agents are excluded;
patients on enzyme-inducing anticonvulsive agents are excluded; patients requiring
strong CYP3A4 or PGP inducers or inhibitors are excluded; patients on steroids for
symptom management must be on a stable dose for 7 days prior to start of treatment.

- Allogeneic stem cell transplant: Patients within 1 year of allogeneic stem cell
transplant, patients with active GVHD or requiring immunosuppression are excluded.

- Previous hypersensitivity to rapamycin or rapamycin derivatives.

- Baseline QTc of >450 msec on EKG OR electrolyte imbalance predisposing to QTc
prolongation (baseline = Grade 1 hypokalemia or hyperkalemia; and baseline = Grade 2
Ca++, Mg++, phosphate abnormalities). Repletion/correction is allowed to achieve
eligibility. Use of QTC prolonging medications will be monitored throughout the trial.
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