Methotrexate Infusion Into Fourth Ventricle in Children With Recurrent Malignant Fourth Ventricular Brain Tumors
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|ClinicalTrials.gov Identifier: NCT02458339|
Recruitment Status : Completed
First Posted : June 1, 2015
Last Update Posted : March 6, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Brain Tumor, Recurrent Malignant Neoplasm of Fourth Ventricle of Brain||Procedure: Ommaya Reservoir Drug: Methotrexate||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||7 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Study of Methotrexate Infusion Into the Fourth Ventricle in Children With Recurrent Malignant Fourth Ventricular Brain Tumors|
|Actual Study Start Date :||June 15, 2015|
|Actual Primary Completion Date :||March 1, 2019|
|Actual Study Completion Date :||March 1, 2019|
3 consecutive cycles of intraventricular methotrexate infusions into implanted fourth ventricle catheter/Ommaya reservoir following surgical catheter placement into fourth ventricle, each cycle will be of 4 weeks duration. During the first 3 weeks, methotrexate will be infused twice weekly on days 1 and 4 (+/- 2 days). The 4th week is a rest week.
Procedure: Ommaya Reservoir
Surgical catheter placement into the fourth ventricle of the brain
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.
- Maximum Tolerated Dose (MTD) of the direct administration of methotrexate into the fourth ventricle of the brain as determined by NCI's CTCAE [ Time Frame: 3 months ]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).
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): NCT02458339
|United States, Texas|
|UTHealth & Children's Memorial Hermann Hospital|
|Houston, Texas, United States, 77030|
|Principal Investigator:||David I Sandberg, MD||UTHealth Medical School|