Clinical trial NCT00883688
Conditions: Brain Cancer Pediatric Cancers
Keywords: Brain Tumor Recurrent Ependymoma Refractory Ependymoma Intracranial ependymoma Ependymoblastoma Subependymoma Myxopapillary Clear cell Anaplastic Bevacizumab Avastin Anti-VEGF Monoclonal Antibody rhuMAb-VEGF Lapatinib Tykerb GW572016
Sponsor: M.D. Anderson Cancer Center
Start date: 2009-07-01; Completion date: 2015-04-01
Enrollment: 24 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The goal of this clinical research study is to learn if the combination of Avastin (bevacizumab) and Tykerb (lapatinib) can help to control ependymoma in pediatric patients. The safety of this drug combination will also be studied.

Detailed description:
The Study Drugs:

Bevacizumab is designed to block the growth of blood vessels that supply nutrients necessary for tumor growth. This may prevent and/or slow down the growth of cancer cells.

Lapatinib is designed to prevent or slow down the growth of cancer cells by blocking proteins inside the cancer cells.

Study Drug Administration:

If you are found to be eligible to take part in this study, you will receive bevacizumab every 2 weeks while you are on study (2 times during each 4-week "study cycle"). The first time you receive the drug, it will be given by vein over 90 minutes. If this dose is well tolerated, you may receive future doses over 30 minutes.

You will take pills of lapatinib 2 times each day while you are on study. The pills should be taken at about the same time each day. You should not eat or drink anything except water for 1 hour before or 1 hour after you take the pills. If you miss a dose, do not take extra pills the next day to try and make up for the missed dose. You should report any missed pills or any trouble you may have with taking the pills to your study doctor.

You will be given a patient diary in which you must record what time you take lapatinib each time.

Study Visits:

At all study visits, you will be asked about any other drugs that you may be taking and about any side effects that you may be experiencing.

During Cycle 1 the following tests and procedures will be performed at least 1 time each week:

* You will have a physical exam, including measurement of your vital signs.
* Your performance status will be recorded.

Two (2) times each week during Cycle 1, blood (about 2-3 teaspoons) will be drawn for routine tests.

At the end of Cycle 1, urine will be collected for routine tests.

On Days 1 and 15 of Cycle 2, the following tests and procedures will be performed:

* You will have a physical exam, including measurement of your vital signs.
* Your performance status will be recorded.
* Blood (about 2-3 teaspoons) will be drawn for routine tests.

At the end of Cycle 2, you will have an MRI scan of your head to check the status of the disease. If your doctor thinks it is needed, you will also have an MRI of your spine and a spinal tap to check your cerebrospinal fluid (CSF) for presence of disease.

On Day 1 of Cycle 3 and beyond, the following tests and procedures will be performed:

* You will have a physical exam, including measurement of your vital signs.
* Your performance status will be recorded.
* Blood (about 2-3 teaspoons) and urine will be collected for routine tests.

Every 8 weeks, starting with the end of Cycle 4, while you are on study, the following tests and procedures will be performed:

* You will have an MRI scan of the brain to check the status of the disease.
* If your doctor thinks it is needed, you will have an MRI scan of the spine to check the status of the disease.
* If your doctor thinks it is needed, you will have a spinal tap to check your CSF for the presence of disease.

Every 12 weeks while you are on study, the following tests and procedures will be performed to check for possible side effects:

* You will have an echocardiogram or a multiple gated acquisition scan (MUGA) (if the study doctor thinks it is necessary) to test your heart function.
* You will have an x-ray of your right knee.
* If your doctor thinks it is needed, you will have an MRI scan of both knees.

Length of Study:

You will be on study for up to 2 years. You will be taken off study if the disease gets worse, if you experience intolerable side effects, or if the doctor thinks it is in your best interest.

End-of-Treatment Visit:

After you have finished receiving the study drugs, the following tests and procedures will be performed:

* You will have a physical exam, including measurement of your vital signs.
* You will be asked about any other drugs that you may be taking and about any side effects that you may be experiencing.
* Your performance status will be recorded.
* Blood (about 2-3 teaspoons) will be collected for routine tests.
* You will have an echocardiogram or a MUGA scan (if the study doctor thinks it is necessary) to test your heart function.
* You will have an x-ray of your right knee.
* You will have MRI scans of the brain and spine to check the status of the disease.
* If your doctor thinks it is needed, you will have a spinal tap to check the status of the disease.

Long-Term Follow-up:

You will have a follow-up visit 30 days after you have finished receiving the study drugs. The following tests and procedures will be performed:

* You will have a physical exam, including measurement of your vital signs.
* You will be asked about any other drugs that you may be taking and about any side effects that you may be experiencing.
* Your performance status will be recorded.
* Blood (about 2-3 teaspoons) will be collected for routine tests.

This is an investigational study. Bevacizumab is FDA approved and commercially available for the treatment of colon, rectum, lung and certain types of breast cancer. Lapatinib is FDA approved and commercially available for the treatment of certain types of breast cancer. The use of this drug combination in ependymomas in pediatric patients is investigational.

Up to 40 patients will take part in this multicenter study. Up to 6 patients will be enrolled at MD Anderson.

Arms: arm 1: Bevacizumab 10 mg/kg given by vein over 90 minutes for first injection (30-60 minutes for subsequent doses) every 2 weeks while on study (2 times during each 4-week "study cycle"). Lapatinib Pills of 700 mg/m\^2/dose given orally 2 times each day.
Interventions: intervention 1: Bevacizumab intervention 2: Lapatinib
Intervention descriptions: intervention 1: 10 mg/kg given by vein over 90 minutes for first injection (30-60 minutes for subsequent doses) every 2 weeks while on study (2 times during each 4-week "study cycle"). intervention 2: Pills of 700 mg/m\^2/dose given orally 2 times each day.

Protocol documents: