Methotrexate Infusion Into the Fourth Ventricle in Children With Malignant Fourth Ventricular Brain Tumors: A Pilot Study

Brain Tumor Clinical Trial

Official title: Methotrexate Infusion Into the Fourth Ventricle in Children With Malignant Fourth Ventricular Brain Tumors: A Pilot Study

Status Completed

Clinical Trial Summary

The goal of this clinical research study is to learn if it is safe to receive methotrexate through the fourth ventricle of the brain in patients with brain tumors.

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.

Clinical Trial Description

Catheter Placement:

If you are eligible to take part in this study, you will have surgery to place a catheter into the ommaya reservoir. The ommaya reservoir is a catheter system that allows drugs to be administered directly to parts of the brain. In this study, the catheter will be used to collect about 1 teaspoon of cerebrospinal fluid (CSF - the fluid surrounding the brain and spinal cord) to check the status of the disease and for the infusion of methotrexate directly into the 4th ventricle of the brain, which is 1 of the 4 connected fluid-filled cavities in the brain.

If the study doctor thinks it is necessary, based on the location of the tumor, the tumor may also be removed while you are already under anesthesia just before the catheter is placed.

Study Drug Administration:

Each cycle is 4 days long and will consist of 4 daily infusions of methotrexate. You will have at least a 2 week rest period between each cycle.

Methotrexate will be infused through the ommaya reservoir catheter directly into the 4th ventricle of the brain starting at least 7 days after the catheter placement surgery. The infusion should last about 3 minutes each time.

You may also be given leucovorin, a drug used to help prevent or treat the side effects of methotrexate, by intravenous (IV) infusion through a catheter or port you have already had placed in your arm. If the study doctor thinks it is needed, this infusion will be given after each cycle to help with the possible side effects you may experience from methotrexate. The infusion should last about 5 minutes each time.

Study Visits:

Within 72 hours after catheter placement surgery:

• Any updates to your health will be recorded.

• You will have an MRI scan of the brain and spine to check the status of the disease and the flow of brain fluid.

Within seven (7) days after catheter placement surgery:

• Any updates to your health will be recorded.

• You will have a neurological exam.

• You will have a spinal tap (also called a lumbar puncture). A lumbar puncture is a procedure where fluid surrounding the spinal cord is removed by inserting a needle into the lower back. The affected area is numbed with local anesthetic during the procedure.

• You will have a neuropsychological test performed by a neuropsychologist. For this test, you will be asked questions that will test your memory and brain function. The test should take about 3 hours.

On Day 1 of each methotrexate infusion for Cycles 1-3:

• You will have a neurological exam.

• Blood (about 1 teaspoon) will be drawn for routine tests.

• If you are able to become pregnant, you will have a urine pregnancy test.

Daily during each methotrexate infusion for Cycles 1-3:

• You will have a neurological exam.

• You will have an Ommaya reservoir tap (a catheter is placed into the Ommaya reservoir to give the methotrexate infusion).

• CSF (about 1 teaspoon) will be collected for routine tests. Blood (about 1 teaspoon each time) will be drawn to learn how much methotrexate is in your blood.

After you have completed Cycle 3:

You will have an MRI scan of the brain and spine to check the status of the disease and the flow of brain fluid.

You will have a spinal tap. You will have a neuropsychological test performed by a neuropsychologist. For this test, you will be asked questions that will test your memory and brain function. The test should take about 3 hours.

If the study doctor thinks it is in your best interest, you will continue with additional cycles of methotrexate therapy, with required tests and procedures. Your doctor may recommend additional surgery. Your doctor will discuss this with you.

Also, if the study doctor thinks it is in your best interest, methotrexate may be given together with other chemotherapy after completion of Cycle 3. If you will be receiving other chemotherapy, the study doctor will speak with you in more detail about what drugs you will receive and how you will receive them.

Length of Study:

You will receive up to 3 cycles of the methotrexate, or as long as the doctor thinks it is your best interest. You will no longer be able to receive the study drug if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.

Your participation on the study will be over after you complete the follow-up visits.

Follow-Up Visit:

3 months after the final dose of study drug:

• Any updates to your health will be recorded.

• You will have a neurological exam.

• You will have an MRI scan of the brain and spine to check the status of the disease.

This is an investigational study. Methotrexate is FDA approved and commercially available for infusion directly into brain tumors. The infusion of methotrexate into the 4th ventricle of the brain is investigational.

Up to 12 patients will be enrolled in this study. All will be enrolled at MD Anderson. ;

Related Conditions & MeSH terms

• Brain Neoplasms
• Brain Tumor
• Malignant Neoplasm of Fourth Ventricle of Brain
• Neoplasms

• NCT number: NCT01737671
• Study type: Interventional
• Source: M.D. Anderson Cancer Center
• Status: Completed
• Phase: Early Phase 1
• Start date: December 27, 2012
• Completion date: January 11, 2018