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

• Status: Not yet recruiting
• Trial end date: 2022-12-30
• Target enrollment: 5
• Participant gender: All

Summary

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The University of Texas Health Science Center, Houston
• Treatments: Panobinostat

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