Infusion of Panobinostat (MTX110) Into the Fourth Ventricle in Children and Adults With Recurrent Medulloblastoma
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ClinicalTrials.gov Identifier: NCT04315064 |
Recruitment Status :
Recruiting
First Posted : March 19, 2020
Last Update Posted : July 1, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Medulloblastoma | Drug: Treatment with MTX110 | Early Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 5 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Infusion of Panobinostat (MTX110) Into the Fourth Ventricle or Tumor Resection Cavity in Children and Adults With Recurrent Medulloblastoma: A Pilot Study |
Actual Study Start Date : | April 21, 2020 |
Estimated Primary Completion Date : | December 30, 2024 |
Estimated Study Completion Date : | December 30, 2024 |

Arm | Intervention/treatment |
---|---|
Experimental: Treatment with MTX110 |
Drug: Treatment with MTX110
Patients will undergo surgery for maximum safe tumor resection with simultaneous placement of a ventricular access device (VAD) into the fourth ventricle or posterior fossa tumor resection cavity.The specific ventricular access device that will be placed is Medtronic Reference number 44102, "Medtronic CSF-Ventricular Reservoir Side Inlet, 18 mm.If a patient already has a ventricular access device in place and additional tumor resection is not required, then that patient can proceed with intraventricular chemotherapy infusions after study enrollment. If the patient has metastatic disease in the brain and/or spine without resectable tumor in the posterior fossa, then only catheter and ventricular access device placement will be performed.Enrolled patients will receive 4 infusions per week of panobinostat (MTX110; 0.25 ml of 300 μM = 26.2 μg), per infusion into the ventricular access device for 6 consecutive weeks for a total of 24 infusions. |
- 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 ]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
- 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) ]Change in disease progression as measured by an MRI
- 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) ]Change in disease progression as measured by lumbar CSF cytology

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Ages Eligible for Study: | 1 Year to 80 Years (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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): NCT04315064
Contact: David IIan Sandberg, MD | (713) 500-7370 | David.I.Sandberg@uth.tmc.edu | |
Contact: Bangning Yu | (713) 500-7363 | Bangning.Yu@uth.tmc.edu |
United States, Texas | |
The University of Texas Health Science Center at Houston | Recruiting |
Houston, Texas, United States, 77030 | |
Contact: David Sandberg, MD 713-500-7370 David.I.Sandberg@uth.tmc.edu | |
Contact: Bangning yu (713) 500-7363 Bangning.Yu@uth.tmc.edu |
Principal Investigator: | David IIan Sandberg, MD | The University of Texas Health Science Center, Houston |
Responsible Party: | David Ilan Sandberg, Professor, The University of Texas Health Science Center, Houston |
ClinicalTrials.gov Identifier: | NCT04315064 |
Other Study ID Numbers: |
HSC-MS-19-0939 |
First Posted: | March 19, 2020 Key Record Dates |
Last Update Posted: | July 1, 2022 |
Last Verified: | June 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
medulloblastoma Malignant Neoplasms, Brain MTX110 panobinostat Antineoplastic |
Medulloblastoma Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal |
Neoplasms by Histologic Type Neoplasms Neuroectodermal Tumors, Primitive Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue |