Protocol
CNS927: Phase 1/2 Study of Suberoylanilide Hydroxamic Acid (SAHA, Vorinostat) and Local Irradiation, Followed by Maintenance SAHA in Children with Newly Diagnosed Diffuse Intrinsic Pontine Gliomas (DIPG)
Diseases
Brain Tumor : Diffuse intrinsic pontine gliomas
Description
Diffuse Intrinsic Pontine Gliomas are a type of brain tumor that occurs in the lowest, stem-like part of the brain. The brain stem connects the brain to the spinal cord. Tumors of the brain stem are hard to treat, but it is important to treat them because the brain stem is the area of the brain that controls your breathing, blood pressure and heart rate. It is hard—and often times impossible—to operate on this area of the brain because it interferes with the functioning of this critical area of the brain. They are usually diagnosed in children aged 5 to 10.
The standard treatment for brainstem tumors has been radiation therapy (treatment with high energy rays to get rid of cancer cells). But, radiation therapy may only work for a short period of time or may not work at all. This therapy can reduce symptoms significantly, but there may be some permanent damage caused by the tumor which can’t be helped. Steroids, another type of drug, are often given to improve some of the symptoms. Surgery is not part of the standard treatment because the tumor has grown within a part of the brain where removal of tumor is impossible. The effectiveness of chemotherapy is still uncertain.
This study is using vorinostat because it seems to work against other types of brain tumors. It is not sure if vorinostat given with radiation therapy will work in people with this kind of brain tumor. Researchers have learned that some of the chemotherapy drugs used to treat people with cancer can make tumor cells respond better to radiation therapy. This study wants to find a way to make the radiation therapy work better to help more people with cancer. Recently, a study of vorinostat in children found the dose that was safe to give to children if given alone.
This study is done in 2 parts. Phase 1 and Phase 2. Both phases use this drug called vorinostat. Vorinostat is considered experimental because it has not been approved by the Food and Drug Administration (FDA) for brain tumors. The important goal of Phase I study is to find the highest dose of vorinostat that can be given safely during radiation therapy and to learn what its side effects are. The important goal of phase 2 study is to determine if vorinostat, when given during radiation therapy at the dose found in phase 1 of the study, is a helpful and effective therapy for treating children with newly diagnosed DIPG. The dose of vorinostat after radiation therapy will be slightly different from its dose during radiation therapy, but this dose was also previously determined to be safe in children in a separate study.
Objectives
- To find the highest safe dose of vorinostat that can be given together with radiation therapy without causing severe side effects;
- To learn what kind of side effects can be caused by vorinostat with radiation therapy
- To learn more about the biology effects of vorinostat on the cells in the patient’s body
- To determine whether vorinostat with radiation therapy, followed by maintenance therapy with vorinostat is a beneficial treatment for this kind of tumor.
Eligibility
- Patient should be greater than 36 months and less than or equal to 21 years of age at enrollment
- Patients with newly diagnosed diffuse intrinsic pontine gliomas
- Patients with juvenile pilocytic astrocytoma, fibrillary, astrocytoma, gangliogliomas, or other mixed gliomas without anaplasia are not eligible.
- Patients must be able to swallow capsules or liquids
- Pregnant or breast-feeding women will not be entered on this study due to risks of fetal and teratogenic adverse events
- Patients who are currently receiving another investigational drug are not eligible.
Contact
Ibrahim Qaddoumi, MD
St. Jude Children’s Research Hospital
262 Danny Thomas Place
Memphis, TN 38105 USA
Phone: (901) 595-2544 or (901) 595-4599
FAX: (901) 595-5353
Or
Tabatha E. Doyle, RN
Coordinator, Brain Tumor Program
Phone: 901-595-2544
For the current eligibility status of this clinical study, patient’s family, relatives and/or referring physicians may contact St. Jude Children’s Research Hospital at (901) 595-4599 or (901) 595-2544.
The above information is intended to provide only a basic description about a research protocol that may be currently active at St. Jude. The details made available here may not be the most up-to-date information on protocols used by St. Jude. To receive full details about a protocol and its status and or use at St. Jude, a physician must contact St. Jude directly.