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.
Title
- Brief Title: Infusion of Panobinostat (MTX110) Into the Fourth Ventricle or Tumor Resection Cavity 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:
NCT04269343
Conditions
Interventions
Drug | Synonyms | Arms |
---|
Treatment with MTX110 | | Treatment 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
Name | Type | Description | Interventions |
---|
Treatment with MTX110 | Experimental | | |
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, dysdiadichokinesis) 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,post last infusion(about 6 weeks) |
Safety Issue: | |
Description: | |
Measure: | Change in disease progression as measured by lumbar CSF cytology |
Time Frame: | prior to first infusion,post last infusion(about 6 weeks) |
Safety Issue: | |
Description: | |
Details
Phase: | Early Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Not yet recruiting |
Lead Sponsor: | The University of Texas Health Science Center, Houston |
Trial Keywords
- medulloblastoma
- Malignant Neoplasms, Brain
- MTX110
- panobinostat
- Antineoplastic
Last Updated
February 11, 2020