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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02458339
Other study ID # HSC-MS-15-0035
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date June 15, 2015
Est. completion date March 1, 2019

Study information

Verified date March 2019
Source The University of Texas Health Science Center, Houston
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal of this clinical research study is to establish the maximum tolerated dose (MTD) of direct administration of methotrexate into the fourth ventricle of the brain in 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, which may slow or stop their growth and spread throughout the body. This may cause the cancer cells to die.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Ommaya Reservoir
Surgical catheter placement into the fourth ventricle of the brain
Drug:
Methotrexate
4, 6, or 8 mg into fourth ventricle of the brain via the Ommaya Reservoir for 2 days a week for 3 weeks with week 4 is a rest week. Each patient will undergo three cycles.

Locations

Country Name City State
United States UTHealth & Children's Memorial Hermann Hospital Houston Texas

Sponsors (1)

Lead Sponsor Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Maximum Tolerated Dose (MTD) of the direct administration of methotrexate into the fourth ventricle of the brain as determined by NCI's CTCAE Maximum Tolerated Dose (MTD) is determined using the criteria established by the National Cancer Institute's (NCI's) Common Terminology Criteria for Adverse Events V4.0 (CTCAE). 3 months
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