A Phase I/II Study Of Topotecan with G-CSF and Radiation Therapy in Children with Malignant Intrinsic Pontine Brainstem Gliomas of Childhood
Date Last Modified: 4-6-2006
Date First Published: 4-6-2006
What is the purpose of this study?
The goals of this study are:
- To find out if the amount of topotecan given before each radiation therapy treatment can be increased 25-50% (compared to the dose used in an earlier study) without causing severe side effects when it is given with G-CSF
- To find out the effects (good and/or bad) of topotecan on subjects or their brainstem tumor
- To find out if treating subjects with topotecan before they get radiation therapy, along with G-CSF, improves overall survival
- To find out (using blood samples) how long topotecan stays in the body
Who will be included in this study?
Patients who are between 3 and 21 years old at the time of diagnosis who have a brainstem glioma may be eligible to participate in this clinical trial.
What is involved?
Patients will be in this study for about 6 ½ weeks. However, patients will still get physical exams and blood tests for 5 years after treatment, so that researchers can watch for any effects of treatment. We would like to continue to find out about patients' health for about 5 years after the study closes to new patients. Keeping This will help us understand the long-term effects of the study.
Standard Medical Tests
Patients who take part in this study will have the following tests and procedures:
- Blood tests
- Urine tests
- Physical exams
- Neurologic exam to check for alertness, muscle strength, coordination, and reflexes
- Magnetic Resonance Imaging (MRI) of brain
- Pregnancy test (for female patients of child bearing age)
- If the tumor grows or gets bigger, a MRI of the spine will also be obtained
- Radiation therapy
- Optional research studies
What are the benefits?
Patients who agree to take part in this research study may experience a direct medical benefit. We hope that the topotecan chemotherapy will help the radiation better control the brain tumor and delay tumor progression, but it is not known if this will happen for the tumor. The information learned from this research study may benefit other patients with brainstem gliomas in the future.
Will I get all the facts about the study?
Parents interested in having their child participate, as well as adult patients/subjects, will be scheduled with a physician who will thoroughly explain all of the details of the study. The physician will review the consent form with the parent/guardian/adult subject and will be sure that all questions are answered. The consent form goes over all of the procedures, the risks, the benefits, the compensation, who to contact with questions or concerns and more. Study procedures will not begin until a parent/guardian or adult subject has signed this form and, if of age, the child has given at minimum his/her verbal agreement.
What are the risks?
A detailed list of side effects will be provided to those patients interested in knowing more about the study.
Who should I contact for more information?
Rebecca Turner, CCRP
Cincinnati Children's Hospital Medical Center
Division of Hematology / Oncology
3333 Burnet Ave.
Cincinnati, OH 45229-3039
Phone: 513-636-2799
cancer@cchmc.org
