Clinical Trial Details
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[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT02899715 : Panobinostat in Treating Younger Patients With Progressive Diffuse Intrinsic Pontine Glioma
PhasePhase 1
AgesMin: 2 Years Max: 21 Years
Eligibility
Inclusion Criteria:

- Patients with progressive DIPG, as defined by progressive neurologic abnormalities or
worsening neurologic status not explained by causes unrelated to tumor progression
(e.g., anticonvulsant or corticosteroid toxicity wean, electrolyte disturbances,
sepsis, hyperglycemia, etc.), OR an increase in the bi-dimensional measurement,
taking as a reference the smallest disease measurement recorded since diagnosis, OR
the appearance of a new tumor lesion since diagnosis

- Please note: patients with a radiographically typical DIPG, defined as a tumor
with a pontine epicenter and diffuse involvement of more than 2/3 of the pons,
are eligible without histologic confirmation

- Patients with pontine lesions that do not meet these radiographic criteria will
be eligible if there is histologic confirmation of malignant glioma World Health
Organization (WHO) II-IV

- Body surface area (BSA)

- Patients must have a BSA >= 0.80 m^2 for dose 5 mg/m^2

- Patients must have a BSA >= 0.65 m^2 for doses of 10 mg/m^2-22 mg/m^2

- Patients must have a BSA >= 0.50 m^2 for doses of 28 mg/m^2-36 mg/m^2

- Patient must be able to swallow capsules whole

- Karnofsky performance scale (KPS for > 16 years of age) or Lansky performance score
(LPS for =< 16 years of age) assessed within 7 days of enrollment must be >= 50%;
patients who are unable to walk because of neurologic deficits, but who are up in a
wheelchair, will be considered ambulatory for the purpose of assessing the
performance score

- Patients must have received a minimum of 54 Gy focal irradiation administered over
approximately 42 days prior to enrollment; patients must have recovered from the
acute treatment-related toxicities (defined as =< grade 1) of all prior chemotherapy,
immunotherapy, or radiotherapy prior to entering this study

- Patients must have received their last dose of known myelosuppressive anticancer
therapy or immunotherapy at least 21 days prior to enrollment (42 days if prior
nitrosourea)

- Biologic or investigational agent (anti-neoplastic): patient must have recovered from
any acute toxicity potentially related to the agent and received their last dose of
the investigational or biologic agent >= 7 days prior to study enrollment

- For agents that have known adverse events occurring beyond 7 days after
administration, this period must be extended beyond the time during which
adverse events are known to occur, and discussed with the principal investigator

- Monoclonal antibody treatment and agents with known prolonged half-lives: at least
three half-lives must have elapsed prior to enrollment

- Note: A list of the half-lives of commonly used monoclonal antibodies is
available on the Pediatric Brain Tumor Consortium (PBTC) webpage under Generic
Forms and Templates

- Patients must have had their last fraction of:

- Craniospinal irradiation or total body 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

- Absolute neutrophil count >= 1,000/mm^3

- Platelets >= 100,000/mm^3 (unsupported, defined as no platelet transfusion within 7
days, and recovery from post-transfusion nadir)

- Hemoglobin >= 8 g/dl (may receive transfusions)

- Total bilirubin =< 1.5 times institutional upper limit of normal (ULN)

- Alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 3 x
institutional upper limit of normal

- Albumin >= 3 g/dl

- Potassium >= lower limit of normal (LLN)

- Serum total calcium (correct for serum albumin) or ionized calcium >= LLN

- Serum creatinine based on age/gender as noted below; patients that do not meet the
criteria below but have a 24-hour creatinine clearance or glomerular filtration rate
(GFR) (radioisotope or iothalamate) >= 70 ml/min/1.73 m^2 are eligible

- 2 to < 6 years: 0.8 mg/dL

- 6 to < 10 years: 1 mg/dL

- 10 to < 13 years: 1.2 mg/dL

- 13 to < 16 years: 1.5 mg/dL (male), 1.4 mg/dL (female)

- >= 16 years: 1.7 mg/dL (male), 1.4 mg/dL (female)

- Cardiac function:

- Left ventricular ejection fraction >= 50 by gated radionuclide study OR
shortening fraction of >= 27% by echocardiogram

- Patient has no ventricular arrhythmias except for benign premature ventricular
contractions

- Patient has a corrected QT (QTc) interval =< 450 ms

- Patients must be off all colony-forming growth factor(s) for at least 7 days prior to
enrollment (i.e. filgrastim, sargramostim or erythropoietin); 14 days must have
elapsed if patients received poly(ethylene glycol) (PEG) formulations

- Patients must agree to avoid grapefruit or grapefruit juice and Seville (sour)
oranges during the entire study

- Female patients of childbearing potential must have a negative serum or urine
pregnancy test

- Female patients with an infant must agree not to breastfeed their infants while on
this study

- Patients of childbearing or child fathering potential must be willing to use a
medically acceptable form of birth control, which includes abstinence, while being
treated on this study and for 3 months after the last dose of panobinostat

- The patient or parent/guardian is able to understand the consent and is willing to
sign a written informed consent document according to institutional guidelines

Exclusion Criteria:

- Patients who have had > 60 Gy total radiation to the pons (e.g. patients who have
received re-irradiation)

- Patients have had prior histone deacetylase (HDAC), deacetylase (DAC), heat shock
protein 90 (HSP90) inhibitors for the treatment of their DIPG

- Patients have had valproic acid within 28 days prior to enrollment

- Patients have had prior bone marrow transplant

- Patients have significant acute deterioration in neurologic status in 72 hours prior
to enrollment, in the opinion of the treating physician

- Patients have any other significant concurrent illness

- Patients have impairment of gastrointestinal (GI) function or GI disease that may
significantly alter the absorption of panobinostat; for example severe inflammatory
bowel disease

- Patients have diarrhea > Common Terminology Criteria for Adverse Events (CTCAE) grade
2

- Patients have any clinically significant unrelated systemic illness (serious
infections or significant cardiac, pulmonary, hepatic or other organ dysfunction),
that in the opinion of the investigator would compromise the patient's ability to
tolerate protocol therapy, put them at additional risk for toxicity or would
interfere with the study procedures, assessments, or results

- Patients have a history of any other malignancy

- Patients are known to be refractory to red blood cell or platelet transfusions

- Patients who are receiving any other anticancer or investigational drug therapy

- Patients who are required to receive any medication which can prolong the QTc
interval

- Patients who in the opinion of the investigator are unwilling or unable to return for
required follow-up visits or obtain follow-up studies required to assess toxicity to
therapy or to adhere to drug administration plan, other study procedures, and study
restrictions
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT02899715      |      Link to official Clinicaltrials.gov listing
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