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Phase I Study of Methotrexate Infusion into the Fourth Ventricle in Children with Recurrent Malignant Fourth Ventricular Brain Tumors

Lead Physician: David Sandberg, M.D.

This study is currently recruiting participants.

The aim of this study is to establish the maximum tolerated dose of administration of methotrexate directly into the fourth ventricle of the brain. The clinical trial is for patients with recurrent malignant brain tumors – including medulloblastoma, primitive neuroectodermal tumors (PNET), atypical teratoid/rhabdoid tumors (AT/RT), and ependymoma.

Methotrexate is designed to block cancer cells from dividing. This may slow or stop their growth and the spread of cancer cells throughout the body. It may also cause the cancer cells to die.

See full study details at clinicaltrials.gov.

Estimated Enrollment:

18

Study Start Date:

May 2015

Estimated Study Completion Date:

May 2018

Criteria

Ages Eligible for Study:

1 Year to 21 Years

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Inclusion Criteria

  1. Diagnosis: Patients with histologically verified medulloblastoma, primitive neuroectodermal tumor (PNET), atypical teratoid/rhabdoid tumor (AT/RT), ependymoma, or choroid plexus carcinoma with recurrence or progression involving the brain and /or spine. Patients with these tumors who did not present at diagnosis in the posterior fossa but have relapsed in the posterior fossa will be eligible. Patients who initially presented with disease in the posterior fossa but have now relapsed outside the posterior fossa will also be eligible.
  2. Patient must have either measurable or evaluable tumor as assessed by MRI of the brain and total spine.
  3. An implanted catheter in the fourth ventricle attached to an Ommaya reservoir or agreement to have one placed.
  4. A minimum of 7 days between last dose of systemic chemotherapy and/or radiation therapy and first infusion of methotrexate into fourth ventricle.
  5. Life expectancy of at least 12 weeks in the opinion of the PI.
  6. Lansky score of 50 or greater if ≤16 years of age or Karnofsky score of 50 or greater if > 16 years of age.
  7. Existing neurological deficits such as weakness, gait instability, cranial nerve deficits, or any other problems caused by the patient's disease or previous treatments must have been stable for a minimum of 1 week prior to study enrollment.
  8. Patients must have recovered from the acute toxic effects of all prior anticancer chemotherapy.
  9. 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 RBC transfusions)
  10. Patient or patient's legal representative, parent (s), or guardian able to provide written informed consent.

Exclusion Criteria

  1. Enrolled in another treatment protocol
  2. Has received another investigational or chemotherapy agent or radiation therapy within 7 days prior to methotrexate infusion into the fourth ventricle
  3. Evidence of untreated infection
  4. Pregnant or lactating women

Contacts

For questions or more information, please contact Marcia Kerr, RN, CCRC at (713) 500-7363 or Marcia.L.Kerr@uth.tmc.edu

For complete information, please visit the study at clinicaltrials.gov.

Sponsor

The University of Texas Health Science Center at Houston Medical School
Dr. David Ilan Sandberg, The University of Texas Health Science Center at Houston Medical School