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NCT02458339 · ClinicalTrials.gov registry record · Phase 1
Methotrexate Infusion Into Fourth Ventricle in Children With Recurrent Malignant Fourth Ventricular Brain Tumors
A Phase 1 study of Brain Tumor, Recurrent and Malignant Neoplasm of Fourth Ventricle of Brain, sponsored by The University of Texas Health Science Center, Houston.
- Completed
- Registry status
- Phase 1
- Development phase
- 7
- Enrollment target
- 1
- Study location
NCT02458339: Completed Phase 1 study of Brain Tumor, Recurrent and Malignant Neoplasm of Fourth Ventricle of Brain, sponsored by The University of Texas Health Science Center, Houston.
NCT02458339 is a Phase 1 study of Brain Tumor, Recurrent and Malignant Neoplasm of Fourth Ventricle of Brain that has completed, run by The University of Texas Health Science Center, Houston. The registered enrollment target is 7 participants, below the 112-participant average among 6 other Brain Tumor, Recurrent trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02458339, a Phase 1 study of Brain Tumor, Recurrent and Malignant Neoplasm of Fourth Ventricle of Brain, has completed, sponsored by The University of Texas Health Science Center, Houston.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 7 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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).
Conditions Studied
Interventions
- DRUG Methotrexate
- PROCEDURE Ommaya Reservoir
Study Locations (1)
Texas
- UTHealth & Children's Memorial Hermann Hospital - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2015-06-15 |
| Est. Completion | 2019-03-01 |
| Phase | Phase 1 |
What the finished NCT02458339 record still lists
NCT02458339 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 112-participant average among 6 other Brain Tumor, Recurrent trials with a reported enrollment target (94% lower).
The record links to 2 conditions, with Brain Tumor, Recurrent appearing as the primary indexed condition, and to 2 interventions - of which Methotrexate is the first listed.
NCT02458339 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT02458339 about?
NCT02458339 is a clinical study titled "Methotrexate Infusion Into Fourth Ventricle in Children With Recurrent Malignant Fourth Ventricular Brain Tumors". 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 ter...
What is the current status of trial NCT02458339?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 7 participants. The study started on 2015-06-15. Estimated completion is 2019-03-01.
What conditions does trial NCT02458339 study?
This clinical trial studies the following conditions: Brain Tumor, Recurrent, Malignant Neoplasm of Fourth Ventricle of Brain.
What interventions are being tested in trial NCT02458339?
The interventions under investigation include: Methotrexate (DRUG), Ommaya Reservoir (PROCEDURE).
Who is sponsoring clinical trial NCT02458339?
This trial is sponsored by The University of Texas Health Science Center, Houston, which has 732 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02458339 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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