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Trial of Panobinostat in Children With Diffuse Intrinsic Pontine Glioma (PBTC-047)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02717455
Recruitment Status : Active, not recruiting
First Posted : March 23, 2016
Last Update Posted : January 13, 2023
Sponsor:
Information provided by (Responsible Party):
Pediatric Brain Tumor Consortium

Study Description
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Brief Summary:

This phase I trial studies the side effects and best dose of panobinostat in treating younger patients with diffuse intrinsic pontine glioma (DIPG). Panobinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Stratum 1 treats patients with DIPG that has returned or gotten worse (progressed). Stratum 2 treats patients with DIPG or H3K27+Thalamic Diffuse Malignant Glioma (DMG) that has not yet gotten worse.

Currently, only Stratum 2 is enrolling patients.


Condition or disease Intervention/treatment Phase
Glioma Drug: LBH589 Phase 1

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Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 53 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1 Trial of Panobinostat in Children With Diffuse Intrinsic Pontine Glioma
Actual Study Start Date : June 28, 2016
Actual Primary Completion Date : February 14, 2022
Estimated Study Completion Date : March 31, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Treatment (STRATUM 1)
Patients with recurrent/progressive DIPG will be enrolled at the time of progression. All patients will take the study drug panobinostat (LBH589).
 Drug: LBH589

STRATUM 1: Recurrent/progressive DIPG. Panobinostat will be given every other day, 3 times/ week, p.o. preferably on Mon/Wed/Fri, for three weeks, followed by one week off of therapy. Three weeks of therapy plus the one week rest period (4 weeks) will constitute one course. Treatment will continue for up to 26 courses (about 2 years) barring progressive disease or unacceptable toxicity.

STRATUM 2: Non-progressed DIPG or H3K27M+ Thalamic DMG. Panobinostat will be given every other day, 3 times/week, every other week p.o. preferably on Mon/Wed/Fri. Four weeks will constitute one course. Treatment will continue for up to 26 courses (about 2 years) unless the patient experiences progressive disease, unacceptable toxicity or any of the off-treatment criteria.

Other Name: Panobinostat
Experimental: Treatment (STRATUM 2)
Patients with non-progressed DIPG or H3K27M+ Thalamic DMG will be enrolled. All patients will take the study drug panobinostat (LBH589).
 Drug: LBH589

STRATUM 1: Recurrent/progressive DIPG. Panobinostat will be given every other day, 3 times/ week, p.o. preferably on Mon/Wed/Fri, for three weeks, followed by one week off of therapy. Three weeks of therapy plus the one week rest period (4 weeks) will constitute one course. Treatment will continue for up to 26 courses (about 2 years) barring progressive disease or unacceptable toxicity.

STRATUM 2: Non-progressed DIPG or H3K27M+ Thalamic DMG. Panobinostat will be given every other day, 3 times/week, every other week p.o. preferably on Mon/Wed/Fri. Four weeks will constitute one course. Treatment will continue for up to 26 courses (about 2 years) unless the patient experiences progressive disease, unacceptable toxicity or any of the off-treatment criteria.

Other Name: Panobinostat


Outcome Measures
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Primary Outcome Measures :
  1. Number of Patients Who Experienced Dose Limiting Toxicities (DLTs) [ Time Frame: 4 weeks ]
    DLTs were defined as adverse events that were at least possibly related to panobinostat that occurred during the first 4 weeks of therapy regardless of expectedness. Hematologic DLTs included grade 4 thrombocytopenia, grade 3 thrombocytopenia with bleeding, grade 3 thrombocytopenia that occurs twice within a treatment course, myelosuppression that causes greater than a 14-day delay between treatment courses, grade 4 neutropenia, grade 3 or 4 febrile neutropenia. Non-hematologic DLTs included any grade 3 or greater non-hematologic toxicities with a few exclusions (such as grade 3 nausea/vomiting that is responsive to antiemetics and that resolves to grade 2 or lower within 5 days, etc.), any grade 2 non-hematological toxicity that persists for more than 7 days and is considered sufficiently medically significant or sufficiently intolerable by patients, and any panobinostat-related non-hematological toxicity that results in a delay of treatment > 14 days between treatment courses.

  2. Maximum Tolerated Dose (MTD) of Panobinostat in Stratum 1 [ Time Frame: 4 weeks ]
    The MTD of panobinostat was defined as the dose at which the continual reassessment method (CRM) estimated that 25% of patients were expected to experience DLTs. Stratum 1 consisted of recurrent or progressive diffuse intrinsic pontine glioma (DIPG) patients who were treated with the "3 times/week, three weeks on, one week off" schedule (1 course = 28 days).

  3. Maximum Tolerated Dose (MTD) of Panobinostat in Stratum 2 [ Time Frame: 4 weeks ]
    The MTD of panobinostat was defined as the dose at which the continual reassessment method (CRM) estimated that 25% of patients were expected to experience DLTs. For Stratum 2, non-progressed DIPG or H3K27+ thalamic diffuse malignant glioma (DMG) patients who completed conventional radiation treatment were eligible. All patients enrolled on this stratum had DIPG tumors and were treated with the "3 times/week, every other week" schedule (1 course = 28 days).

  4. Volume of Distribution (Vd) [ Time Frame: Up to day 3 ]
    Plasma samples for pharmacokinetic (PK) analysis were drawn at pre-dose and at 0.5, 1, 2, 4, 8 (±1), 24 (±4) hours after the first dose of panobinostat, as well as prior to the second dose on Course 1 Day 3. Volume of distribution (Vd) was estimated using a noncompartmental method.

  5. Elimination Rate (Kel) [ Time Frame: Up to day 3 ]
    Plasma samples for pharmacokinetic (PK) analysis were drawn at pre-dose and at 0.5, 1, 2, 4, 8 (±1), 24 (±4) hours after the first dose of panobinostat, as well as prior to the second dose on Course 1 Day 3. Elimination rate (Kel) was estimated using a noncompartmental method.

  6. Half-life (t1/2) [ Time Frame: Up to day 3 ]
    Plasma samples for pharmacokinetic (PK) analysis were drawn at pre-dose and at 0.5, 1, 2, 4, 8 (±1), 24 (±4) hours after the first dose of panobinostat, as well as prior to the second dose on Course 1 Day 3. Half-life (t1/2) was estimated using a noncompartmental method.

  7. Clearance (CL/F) [ Time Frame: Up to day 3 ]
    Plasma samples for pharmacokinetic (PK) analysis were drawn at pre-dose and at 0.5, 1, 2, 4, 8 (±1), 24 (±4) hours after the first dose of panobinostat, as well as prior to the second dose on Course 1 Day 3. Clearance (CL/F) was estimated using a noncompartmental method.

  8. Area under the Curve (AUC) [ Time Frame: Up to day 3 ]
    Plasma samples for pharmacokinetic (PK) analysis were drawn at pre-dose and at 0.5, 1, 2, 4, 8 (±1), 24 (±4) hours after the first dose of panobinostat, as well as prior to the second dose on Course 1 Day 3. The area under the curve (AUC) was estimated using a noncompartmental method and calculated from time of dosing to the last measurable concentration.


Secondary Outcome Measures :
  1. Progression-free Survival (PFS) in Stratum 1 [ Time Frame: From date on treatment until date of PD or death due to any cause or date of last follow-up ]
    PFS was measured from the time of treatment initiation until the time of progressive disease (PD) or death due to any cause for patients with an event, or until the time of last follow-up for patients who were progression free.

  2. Overall Survival (OS) in Stratum 1 [ Time Frame: From date on treatment until date of death due to any cause or date of last follow-up ]
    OS was measured from the time of treatment initiation until the time of death due to any cause for patients who died, or until the time of last follow-up for patients who survived.

  3. Progression-free Survival (PFS) in Stratum 2 [ Time Frame: From date on treatment until date of PD or death due to any cause or date of last follow-up ]
    PFS was measured from the time of treatment initiation until the time of progressive disease (PD) or death due to any cause for patients with an event, or until the time of last follow-up for patients who were progression free.

  4. Overall Survival (OS) in Stratum 2 [ Time Frame: From date on treatment until date of death due to any cause or date of last follow-up ]
    OS was measured from the time of treatment initiation until the time of death due to any cause for patients who died, or until the time of last follow-up for patients who survived.

  5. Percentage of Patients with H3F3A K27M Mutation Detected in Blood Samples [ Time Frame: Blood samples were collected for cell-free DNA based assay at Course 1 Day 1 (C1D1), C2D1, C4D1, and C6D1. ]
    Cell-free DNA based assay was used to determine whether H3F3A K27M mutation could be detected in patients' blood samples. Percentage of patients in whom this mutation was detected was summarized within each stratum and at each time point.

  6. Percentage of Patients with Hist1H3B K27M Mutation Detected in Blood Samples [ Time Frame: Blood samples were collected for cell-free DNA based assay at Course 1 Day 1 (C1D1), C2D1, C4D1, and C6D1. ]
    Cell-free DNA based assay was used to determine whether Hist1H3B K27M mutation could be detected in patients' blood samples. Percentage of patients in whom this mutation was detected was summarized within each stratum and at each time point.

  7. Percentage of Patients with H3F3A K27M Mutation Detected in Urine Samples [ Time Frame: Urine samples were collected for cell-free DNA based assay at Course 1 Day 1 (C1D1), C2D1, C4D1, and C6D1. ]
    Cell-free DNA based assay was used to determine whether H3F3A K27M mutation could be detected in patients' urine samples. Percentage of patients in whom this mutation was detected was summarized within each stratum and at each time point.

  8. Percentage of Patients with Hist1H3B K27M Mutation Detected in Urine Samples [ Time Frame: Urine samples were collected for cell-free DNA based assay at Course 1 Day 1 (C1D1), C2D1, C4D1, and C6D1. ]
    Cell-free DNA based assay was used to determine whether Hist1H3B K27M mutation could be detected in patients' urine samples. Percentage of patients in whom this mutation was detected was summarized within each stratum and at each time point.


Eligibility Criteria
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Ages Eligible for Study:   2 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

STRATUM 1 - INCLUSION CRITERIA

  • DIAGNOSIS - Patients with progressive DIPG or H3K27M+ Thalamic DMG , 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 WHO II-IV.
    • Thalamic Diffuse Midline Glioma patients will be eligible if there is tissue confirmation of the H3K27M mutation by immunohistochemistry or by gene testing performed in a CLIA certified laboratory of the investigator's choice.
  • AGE - Patients must be ≥ 2 but < 22 years of age at the time of enrollment.

  • BSA

    • Patients must have a BSA ≥ 0.80 m2 for dose 5mg/m2.
    • Patients must have a BSA ≥ 0.65 m2 for doses of 10mg/m2 - 22 mg/m2.
    • Patients must have a BSA ≥ 0.50 m2 for doses of 28 mg/m2 - 36 mg/m2.
  • ABILITY TO SWALLOW - Patient must be able to swallow capsules whole.
  • PERFORMANCE STATUS - 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.
  • PRIOR THERAPY - 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.
  • MYELOSUPPRESSIVE CHEMOTHERAPY - 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).

  • INVESTIGATIONAL/ BIOLOGIC AGENT:

    • 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 PBTC webpage under Generic Forms and Templates.)

  • RADIATION THERAPY - 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

  • ORGAN FUNCTION - Patients must have adequate organ and marrow function as defined below:

    • Absolute neutrophil count ≥ 1,000/mm3
    • Platelets ≥ 100,000/ mm3 (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)
    • ALT(SGPT) < 3 x institutional upper limit of normal
    • Albumin ≥ 3 g/dl
    • Potassium ≥ 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 GFR (radioisotope or iothalamate) ≥ 70 ml/min/1.73 m2 are eligible. Maximum Serum Creatinine for age/gender:

      • Age 2 to < 6 years: 0.8 mg/dL (male); 0.8 mg/dL (female)
      • Age 6 to < 10 years: 1 mg/dL (male); 1 mg/dL (female)
      • Age 10 to < 13 years: 1.2 mg/dL (male); 1.2 mg/dL (female)
      • Age 13 to < 16 years: 1.5 mg/dL (male); 1.4 mg/dL (female)
      • Age ≥ 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 QTc interval < 450 ms.
  • GROWTH FACTORS - 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 PEG formulations.
  • FRUIT - Patients must agree to avoid grapefruit or grapefruit juice and Seville (sour) oranges during the entire study.
  • PREGNANCY STATUS - Female patients of childbearing potential must have a negative serum or urine pregnancy test.
  • PREGNANCY PREVENTION - 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.
  • INFORMED CONSENT - 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.

STRATUM 1 - EXCLUSION CRITERIA

  • PRIOR THERAPY

    • Patients who have had > 60 Gy total radiation to the pons (e.g. patients who have received re-irradiation).
    • Patients have had prior HDAC, DAC, 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.
  • NEUROLOGICAL STATUS - Patients have significant acute deterioration in neurologic status in 72 hours prior to enrollment, in the opinion of the treating physician.

  • GASTROINTESTINAL

    • Patients have impairment of GI function or GI disease that may significantly alter the absorption of panobinostat; for example severe inflammatory bowel disease.
    • Patients have diarrhea > CTCAE grade 2.
  • SYSTEMIC ILLNESS - 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 ability of the patient to tolerate protocol therapy or put them at additional risk for toxicity or would interfere with the study procedures or results.
  • OTHER MALIGNANCY - Patients have a history of any other malignancy.
  • TRANSFUSIONS - Patients are known to be refractory to red blood cell or platelet transfusions.

  • CONCURRENT THERAPY

    • 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. Please see Protocol Appendix B: Medications Which May Cause QTc Prolongation.
  • BREASTFEEDING - Female patient IS breastfeeding.
  • INABILITY TO PARTICIPATE - 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

STRATUM 2 - INCLUSION CRITERIA

  • DIAGNOSIS - Patients with DIPG who have not yet progressed by clinical or radiographic criteria.

    • 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 WHO II-IV.
  • AGE - Patients must be ≥ 2 but < 22 years of age at the time of enrollment.
  • BSA Patients must have a BSA ≥ 0.80 m2 for dose 5mg/m2. Patients must have a BSA ≥ 0.65 m2 for doses of 10mg/m2 - 22 mg/m2. Patients must have a BSA ≥ 0.50 m2 for doses of 28 mg/m2 - 36 mg/m2.
  • ABILITY TO SWALLOW - Patient must be able to swallow capsules whole.
  • PERFORMANCE STATUS - 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.

  • PRIOR THERAPY - Patients must have received a minimum of 54 Gy focal irradiation administered over approximately 42 days prior to enrollment. Patients must not have received any other prior therapy for treatment of their CNS malignancy besides standard radiation therapy.

    o Patients must have recovered from the acute treatment-related toxicities (defined as < grade 1) of radiotherapy prior to entering this study.

  • 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.

  • ORGAN FUNCTION - Patients must have adequate organ and marrow function as defined below:

    • Absolute neutrophil count ≥ 1,000/mm3
    • Platelets ≥ 100,000/ mm3 (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)
    • ALT(SGPT) < 3 x institutional upper limit of normal
    • Albumin ≥ 3 g/dl
    • Potassium ≥ 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 in Table 9 but have a 24-hour Creatinine Clearance or GFR (radioisotope or iothalamate) ≥ 70 ml/min/1.73 m2 are eligible.

      • Age 2 to < 6 years: 0.8 mg/dL (male); 0.8 mg/dL (female)
      • Age 6 to < 10 years: 1 mg/dL (male); 1 mg/dL (female)
      • Age 10 to < 13 years: 1.2 mg/dL (male); 1.2 mg/dL (female)
      • Age 13 to < 16 years: 1.5 mg/dL (male); 1.4 mg/dL (female)
      • Age ≥ 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 QTc interval < 450 ms.
  • GROWTH FACTORS - 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 PEG formulations.
  • FRUIT - Patients must agree to avoid grapefruit or grapefruit juice and Seville (sour) oranges during the entire study.
  • PREGNANCY STATUS - Female patients of childbearing potential must have a negative serum or urine pregnancy test.
  • PREGNANCY STATUS - 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.
  • INFORMED CONSENT - 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.

STRATUM 2 - EXCLUSION CRITERIA

  • PRIOR THERAPY - Patients who have had > 60 Gy total radiation to the pons or thalamus (e.g. patients who have received re-irradiation)
  • NEUROLOGICAL STATUS - Patients have significant acute deterioration in neurologic status in 72 hours prior to enrollment, in the opinion of the treating physician.

  • GASTROINTESTINAL

    • Patients have impairment of GI function or GI disease that may significantly alter the absorption of panobinostat; for example severe inflammatory bowel disease.
    • Patients have diarrhea > CTCAE grade 2.
  • SYSTEMIC ILLNESS - 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 ability of the patient to tolerate protocol therapy or put them at additional risk for toxicity or would interfere with the study procedures or results.
  • OTHER MALIGNANCY - Patients have a history of any other malignancy.
  • TRANSFUSIONS - Patients are known to be refractory to red blood cell or platelet transfusions.

  • CONCURRENT THERAPY

    • 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. Please see Appendix B: Medications Which May Cause QTc Prolongation.
  • BREASTFEEDING - Female patient is breastfeeding.
  • INABILITY TO PARTICIPATE - 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02717455


Locations
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United States, California
Children's Hospital Los Angeles
Los Angeles, California, United States, 90026
Stanford University and Lucile Packard Children's Hospital
Palo Alto, California, United States, 94304
United States, District of Columbia
Children's National Medical Center
Washington, District of Columbia, United States, 20010
United States, Illinois
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States, 60611
United States, Maryland
National Cancer Institute
Bethesda, Maryland, United States, 20892
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
United States, Pennsylvania
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15224
United States, Tennessee
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
Sponsors and Collaborators
Pediatric Brain Tumor Consortium
Investigators
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Principal Investigator: Michelle Monje, MD, Phd Stanford University
More Information
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Responsible Party: Pediatric Brain Tumor Consortium
ClinicalTrials.gov Identifier: NCT02717455    
Obsolete Identifiers: NCT02899715
Other Study ID Numbers: PBTC-047
First Posted: March 23, 2016    Key Record Dates
Last Update Posted: January 13, 2023
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Pediatric Brain Tumor Consortium:
Diffuse Intrinsic Pontine Glioma
Diffuse Midline Glioma
H3K27M
DIPG
DMG
Additional relevant MeSH terms:
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Glioma
Diffuse Intrinsic Pontine Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Brain Stem Neoplasms
Infratentorial Neoplasms
Brain Neoplasms
 Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Panobinostat
Antineoplastic Agents
Histone Deacetylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action