Carboplatin and Bevacizumab for Recurrent Ependymoma
The goal of this clinical research study is to learn if the combination of bevacizumab and carboplatin can help to control recurrent ependymoma. The safety of this drug combination will also be studied.
Glial Tumour of Brain
Ependymal Tumour of Brain
Spinal Cord Ependymoma
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Trial of Carboplatin and Bevacizumab for the Treatment of Recurrent Low-Grade and Anaplastic Supratentorial, Infratentorial and Spinal Cord Ependymoma in Adults|
- Number of Participants with Progression-Free Survival at 1 Year [ Time Frame: 1 year following treatment ] [ Designated as safety issue: No ]Progression-Free Survival (PFS) defined as length of time during and after treatment in which a patient is living with a disease that does not get worse.
|Study Start Date:||March 2011|
|Estimated Primary Completion Date:||March 2016 (Final data collection date for primary outcome measure)|
Experimental: Bevacizumab + Carboplatin
Bevacizumab 10 mg/kg by vein on days 1 and 15 of each 28 day cycle. Carboplatin AUC=5 mg/mL/min by vein on day 1 of each 28 day cycle.
10 mg/kg by vein on days 1 and 15 of each 28 day cycle.
Other Names:Drug: Carboplatin
AUC=5 mg/mL/min by vein on day 1 of each 28 day cycle.
Other Name: Paraplatin
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The Study Drugs:
Carboplatin is designed to interfere with the growth of cancer cells by stopping cell division, which may cause the cells to die.
Bevacizumab is designed to prevent or slow down the growth of cancer cells by blocking the growth of blood vessels.
Study Drug Administration:
If you are found to be eligible to take part in this study, you will receive carboplatin by vein over 30 minutes on Day 1 of each 28-day cycle. You will receive bevacizumab by vein over 90 minutes on Days 1 and 15 of each cycle.
-Blood (about 1 - 2 teaspoons) will be drawn for routine tests.
Every 4 weeks:
- Urine will be collected to check your kidney function.
- You will be asked about any drugs you may be taking and if you have had any side effects.
Every 8 weeks:
- Your medical history will be recorded.
- You will have a physical exam, including measurement of your vital signs.
- You will have a neurological exam.
- Your performance status will be recorded.
- You will complete the quality of life questionnaire.
- You will have an MRI scan or CT scan of the head and/or spine to check the status of the disease.
At any time during the study, extra tests may be performed if the doctor thinks they are needed for your safety. The study doctor will tell you more about any extra tests.
Length of Study:
You will receive up to 6 cycles of the study drug combination. You will be taken off study early if the disease gets worse or you experience intolerable side effects.
If the disease has not gotten worse after 6 cycles of receiving the study drug combination, you will be able to continue receiving bevacizumab alone for as long as the doctor thinks it is in your best interest. You will continue to follow the same study visit schedule detailed above.
If you go off study because the disease got worse or you experienced intolerable side effects, the study staff will call you every 3 months from then on to check your health. Each phone call should take about 5 minutes.
This is an investigational study. Carboplatin is FDA approved and commercially available for the treatment of advanced ovarian cancer. Bevacizumab is FDA approved and commercially available for the treatment of glioblastoma multiforme (a type of brain tumor). The use of these drugs in combination in ependymoma is investigational.
Up to 46 patients will take part in this study. Up to 25 patients will be enrolled at MD Anderson.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01295944
|Contact: Mark R. Gilbert, MD,BS||713-792-2883|
|United States, Massachusetts|
|Massachusetts General Hospital||Recruiting|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator: Elizabeth R. Gerstner, M.D.|
|United States, New York|
|Memorial Sloan Kettering Cancer Center||Recruiting|
|New York, New York, United States, 10065|
|Principal Investigator: Martin Fleisher, M.D.|
|United States, Texas|
|UT MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Principal Investigator: Mark R. Gilbert, MD|
|Principal Investigator:||Mark R. Gilbert, MD,BS||UT MD Anderson Cancer Center|
|Study Chair:||Antonio Omuro, MD||Memorial Sloan-Kettering Cancer, CERN Lead Site|