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Phase II Study of Intraventricular Methotrexate in Children With Recurrent or Progressive Malignant Brain Tumors

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ClinicalTrials.gov Identifier: NCT02684071
Recruitment Status : Recruiting
First Posted : February 17, 2016
Last Update Posted : March 2, 2018
Sponsor:
Information provided by (Responsible Party):
Ziad Khatib, Nicklaus Children's Hospital f/k/a Miami Children's Hospital

Brief Summary:
The purpose of this research study is to test an experimental treatment method for recurrent or progressive brain tumors in children aged from 0-22 years. The use of methotrexate and chemotherapy (topotecan and cyclophosphamide) is experimental in this study. This means that their use by themselves or together has not been approved by the U.S. Food and Drug Administration for this usage.

Condition or disease Intervention/treatment Phase
Recurrent Childhood Medulloblastoma Recurrent Childhood Ependymoma Childhood Atypical Teratoid/Rhabdoid Tumor Embryonal Tumor With Abundant Neuropil and True Rosettes Metastatic Malignant Neoplasm to the Leptomeninges Drug: Intra thecal methotrexate Drug: topotecan Drug: cyclophosphamide Phase 2

Detailed Description:
The purpose of this research study is to test an experimental treatment method for recurrent or progressive brain tumors in children aged from 0-22 years. The use of methotrexate and chemotherapy (topotecan and cyclophosphamide) is experimental in this study. This means that their use by themselves or together has not been approved by the U.S. Food and Drug Administration for this usage. This study will attempt to determine via serial MRI scans if methotrexate administration into the lateral or fourth ventricle in combination with systemic intravenous topotecan and cyclophosphamide is effective in reducing tumor burden in the brain and spine for patients with recurrent or progressive brain tumors, including medulloblastoma, ependymoma, PNET (Primitive Neuroectodermal Tumor), atypical teratoid/rhabdoid tumor (AT/RT), and other malignant embryonal tumors. In addition, the study will evaluate the toxicity of the above mentioned experimental treatment during a two-year progression-free survival and survival of children with recurrent malignant brain tumors.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Intraventricular Methotrexate With Systemic Topotecan and Cyclophosphamide in Children With Recurrent or Progressive Malignant Brain Tumors
Study Start Date : February 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : February 2020


Arm Intervention/treatment
Experimental: Intra thecal methotrexate
IT methotrexate via Ommaya reservoir with concomitant systemic topotecan and cyclophosphamide
Drug: Intra thecal methotrexate
IT methotrexate via Ommaya reservoir with concomitant systemic topotecan and cyclophosphamide
Other Name: Intra thecal methotrexate, topotecan and cyclophosphamide

Drug: topotecan
To be administered in conjunction with methotrexate
Other Name: Intra thecal methotrexate, topotecan and cyclophosphamide

Drug: cyclophosphamide
To be administered in conjunction with methotrexate and topotecan
Other Name: Intra thecal methotrexate, topotecan and cyclophosphamide




Primary Outcome Measures :
  1. Tumor response [ Time Frame: 6 months ]
    MRI response


Secondary Outcome Measures :
  1. Toxicity of chemotherapy regimen (topotecan and cyclophosphamide) [ Time Frame: 6 months ]
    Laboratory results, MRI, physical examination



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Ages Eligible for Study:   up to 22 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Recurrent or progressive supratentorial or posterior fossa tumors with measurable disease on imaging studies of the brain and spine or CSF cytology.
  • Tumor histology, including: Medulloblastoma , PNET, or other embryonal tumor, Atypical teratoid/rhaboid tumor (AT/RT), and Ependymoma.
  • Leptomeningeal dissemination of a previously diagnosed CNS tumor.
  • Diagnosis of tumor pathology will be based upon pathology diagnosis from previous surgeries for patients with recurrent tumors.
  • Patients must have received prior radiation before current recurrence, unless the patient is less than 36 months old at diagnosis and has progressed after at least one upfront chemotherapy regimen in which case no prior radiation is required.
  • Patients must have a life expectancy of at least 12 weeks as indicated by the patient's oncologist and/or neurosurgeon.
  • Lansky or Karnofsky Performance status of at least 50.
  • Negative pregnancy test.
  • Specific organ function requirements for: Central Nervous System, Bone Marrow, renal and liver.

Exclusion Criteria:

  • Patients that do not meet the inclusion criteria above.
  • Pregnant or lactating female patients.
  • Patients currently enrolled in another experimental treatment protocol.
  • Patients with documented allergies to any of the chemotherapy agents used in this study.
  • Patient/Parent refuses study participation.
  • Patient is severely somnolent or comatose.
  • Unable or unwilling to commit to return or to follow-up visits.

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): NCT02684071


Contacts
Contact: Ziad Khatib, MD 305-662-8360 ziad.khatib@mch.com
Contact: Jenny Esteves 786-624-2854 jenny.esteves@mch.com

Locations
United States, Florida
Nicklaus Children's Hospital Recruiting
Miami, Florida, United States, 33155
Contact: Ziad A Khatib, MD    305-662-8386    ziad.khatib@mch.com   
Contact: Matthew Bittle, Supervisor    786-624-2838    matthew.bittle@nicklaushealth.org   
Sub-Investigator: John Ragheb, MD         
Sub-Investigator: Guillermo De Angulo, MD         
Sub-Investigator: Sanjiv Bhatia, MD         
Sub-Investigator: Toba Niazi, MD         
Sub-Investigator: David Sandberg, MD         
Sub-Investigator: Ana Diaz, ARNP         
Principal Investigator: Ziad A Khatib, MD         
Sponsors and Collaborators
Nicklaus Children's Hospital f/k/a Miami Children's Hospital
Investigators
Principal Investigator: Ziad Khatib, MD Nicklaus Children's Hospital

Additional Information:
Publications of Results:
Other Publications:
Responsible Party: Ziad Khatib, Director of Neuro-Oncology, Nicklaus Children's Hospital f/k/a Miami Children's Hospital
ClinicalTrials.gov Identifier: NCT02684071     History of Changes
Other Study ID Numbers: NCH-CNS-1601
First Posted: February 17, 2016    Key Record Dates
Last Update Posted: March 2, 2018
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Ziad Khatib, Nicklaus Children's Hospital f/k/a Miami Children's Hospital:
medulloblastoma, ependymoma, AT/RT, embryonal

Additional relevant MeSH terms:
Medulloblastoma
Methotrexate
Neoplasms
Brain Neoplasms
Ependymoma
Rhabdoid Tumor
Neoplasms, Second Primary
Neuroectodermal Tumors, Primitive
Meningeal Carcinomatosis
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms, Complex and Mixed
Meningeal Neoplasms
Cyclophosphamide
Topotecan
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents