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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04315064
Recruitment Status : Recruiting
First Posted : March 19, 2020
Last Update Posted : March 24, 2020
Sponsor:
Collaborator:
Midatech Pharma US Inc.
Information provided by (Responsible Party):
David Ilan Sandberg, The University of Texas Health Science Center, Houston

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 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.

Condition or disease Intervention/treatment Phase
Medulloblastoma Drug: Treatment with MTX110 Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5 participants
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
Estimated Study Start Date : March 19, 2020
Estimated Primary Completion Date : December 30, 2022
Estimated Study Completion Date : December 30, 2022

Resource links provided by the National Library of Medicine


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; 0.5 ml of 300 μM = 52.4 μg), per infusion into the ventricular access device for 6 consecutive weeks for a total of 24 infusions.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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
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

Information from the National Library of Medicine

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


Contacts
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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

Locations
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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   
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Midatech Pharma US Inc.
Investigators
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Principal Investigator: David IIan Sandberg, MD The University of Texas Health Science Center, Houston

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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: March 24, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by David Ilan Sandberg, The University of Texas Health Science Center, Houston:
medulloblastoma
Malignant Neoplasms, Brain
MTX110
panobinostat
Antineoplastic
Additional relevant MeSH terms:
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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
Panobinostat
Antineoplastic Agents
Histone Deacetylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action