Clinical Trials /

Infusion of Panobinostat (MTX110) Into the Fourth Ventricle in Children and Adults With Recurrent Medulloblastoma

NCT04315064

Description:

The purpose of this study is to establish the safety of infusions of panobinostat (MTX110) into the fourth ventricle of the brain or tumor resection cavity in patients with recurrent medulloblastoma and to assess the antitumor activity of simultaneous infusions of panobinostat (MTX110) into the fourth ventricle of the brain or resection cavity in patients with recurrent medulloblastoma based upon MRI scans and lumbar cerebrospinal fluid (CSF) cytology.

Related Conditions:
  • Medulloblastoma
Recruiting Status:

Recruiting

Phase:

Early Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Infusion of Panobinostat (MTX110) Into the Fourth Ventricle in Children and Adults With Recurrent Medulloblastoma
  • Official Title: Infusion of Panobinostat (MTX110) Into the Fourth Ventricle or Tumor Resection Cavity in Children and Adults With Recurrent Medulloblastoma: A Pilot Study

Clinical Trial IDs

  • ORG STUDY ID: HSC-MS-19-0939
  • NCT ID: NCT04315064

Conditions

  • Medulloblastoma

Interventions

DrugSynonymsArms
Treatment with MTX110Treatment with MTX110

Purpose

The purpose of this study is to establish the safety of infusions of panobinostat (MTX110) into the fourth ventricle of the brain or tumor resection cavity in patients with recurrent medulloblastoma and to assess the antitumor activity of simultaneous infusions of panobinostat (MTX110) into the fourth ventricle of the brain or resection cavity in patients with recurrent medulloblastoma based upon MRI scans and lumbar cerebrospinal fluid (CSF) cytology.

Trial Arms

NameTypeDescriptionInterventions
Treatment with MTX110Experimental
  • Treatment with MTX110

Eligibility Criteria

        Inclusion Criteria:

          -  Diagnosis: Patients with histologically verified medulloblastoma with recurrence or
             progression involving anywhere in the brain and/or spine.

          -  Patient must have either measurable or evaluable tumor as assessed by MRI of the brain
             and total spine

          -  An implanted catheter in the fourth ventricle or posterior fossa tumor cavity attached
             to a ventricular access device or agreement to have one placed.

          -  A minimum of 7 days between last dose of systemic chemotherapy and/or radiation
             therapy and first infusion of chemotherapy into fourth ventricle

          -  Life expectancy of at least 12 weeks in the opinion of the principal investigator

          -  Lansky score of 50 or greater if ≤16 years of age or Karnofsky score of 50 or greater
             if > 16 years of age

          -  Existing neurological deficits must have been stable for a minimum of 1 week prior to
             study enrollment

          -  Patients must have recovered from the acute toxic effects of all prior anticancer
             chemotherapy

          -  Adequate bone marrow function defined by peripheral absolute neutrophil count (ANC) ≥
             500/µL, platelet count ≥ 50,000/µL (transfusion independent), and hemoglobin ≥ 9.0
             gm/dL (may receive red blood cells(RBC) transfusions)

          -  Patient or patient's legal representative, parent(s), or guardian able to provide
             written informed consent.

          -  Patient with prolonged QT interval on screening EKG will need cardiology consultation
             prior to enrollment

          -  Patients with abnormal liver function tests (ALT, Aspartate Aminotransferase(AST),or
             total bilirubin) will need gastroenterology consultation prior to enrollment

        Exclusion Criteria:

          -  Enrolled in another treatment protocol

          -  Has received another investigational or chemotherapy agent or radiation therapy within
             7 days prior to intraventricular chemotherapy infusions

          -  Evidence of untreated infection

          -  Pregnant or lactating women
      
Maximum Eligible Age:80 Years
Minimum Eligible Age:1 Year
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Number of participants with grade 3 through grade 5 new neurological adverse events that are related to study drug
Time Frame:4 months post intervention
Safety Issue:
Description:Anew neurological deficit will be defined as new cranial neuropathy, change in level of consciousness, motor weakness, gait change or cerebellar finding (ataxia, dysmetria, dysdiadochokinesis) and will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.0

Secondary Outcome Measures

Measure:Change in disease progression as measured by an MRI
Time Frame:prior to first infusion; after last infusion (last infusion is about 6 weeks after the first infusion)
Safety Issue:
Description:Change in disease progression as measured by an MRI
Measure:Change in disease progression as measured by lumbar CSF cytology
Time Frame:prior to first infusion; after last infusion (last infusion is about 6 weeks after the first infusion)
Safety Issue:
Description:Change in disease progression as measured by lumbar CSF cytology

Details

Phase:Early Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:The University of Texas Health Science Center, Houston

Trial Keywords

  • medulloblastoma
  • Malignant Neoplasms, Brain
  • MTX110
  • panobinostat
  • Antineoplastic

Last Updated

March 20, 2020