Status:
COMPLETED
Infusion of Panobinostat (MTX110) Into the Fourth Ventricle in Children and Adults with Recurrent Medulloblastoma
Lead Sponsor:
The University of Texas Health Science Center, Houston
Collaborating Sponsors:
Midatech Pharma plc
Conditions:
Medulloblastoma
Eligibility:
All Genders
1-80 years
Phase:
EARLY_PHASE1
Brief 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 a...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 21 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 2 2023
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT04315064
Start Date
April 21 2020
End Date
May 2 2023
Last Update
March 10 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
The University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030