Protocol

CNS822: A Randomized Phase II/III Study of Vorinostat and Local Irradiation OR Temozolomide and Local Irradiation OR Bevacizumab and Local Irradiation Followed by Maintenance Bevacizumab and Temozolomide in Children with Newly Diagnosed High-Grade Gliomas

Diseases

Brain Tumor : Newly diagnosed high grade gliomas

Description

A glioma is a type of tumor that starts in the brain or spine. A “high-grade” glioma is a tumor that grows fast and is more likely to spread. Standard treatment for high-grade gliomas includes surgery to remove as much tumor as possible followed by radiation therapy. Treatment may also include chemotherapy during and/or after radiation treatment. High-grade gliomas are hard to treat successfully. Study doctors want to find treatments that will be better at getting rid of or shrinking high-grade gliomas. This study will evaluate different chemotherapy drugs during radiation therapy. Two drugs that will be used in this study are vorinostat and bevacizumab. Early studies have shown that vorinostat and bevacizumab may help radiation therapy work better to get rid of cancer cells.

Temozolomide is one of the chemotherapy drugs often used during radiation therapy to treat newly diagnosed high-grade glioma. Anti-cancer drugs, such as temozolomide, are also commonly used in maintenance therapy for newly diagnosed high-grade glioma. Maintenance therapy is the use of chemotherapy after radiation therapy.

Study doctors also want to see if using different drugs during maintenance therapy will be better than treatment with temozolomide in helping to get rid of or shrink high-grade gliomas. Another drug that they want to try together with temozolomide is bevacizumab. Study doctors want to find out if adding bevacizumab to treatment with temozolomide during maintenance therapy will work better than temozolomide alone. Bevacizumab is a drug that works differently than traditional chemotherapy drugs. Cancer cells need to have a blood supply just as normal body cells do. Bevacizumab is an antibody that works to stop the growth of blood vessels in the tumor. Study doctors think the combination of temozolomide and bevacizumab will be well-tolerated by children who take part in this study, and that the combination therapy may work better.

This study is being done in 3 phases:

Phase 1 of this study is to find the dose of vorinostat that can be given safely to children and adolescents during radiation therapy. All of the patients in this phase will receive vorinostat during radiation therapy followed by maintenance therapy using bevacizumab with temozolamide. This phase has been completed.

Phase 2 will be to evaluate 3 different treatments to determine which two of the three have the greatest effect on high-grade gliomas . This phase will be broken down into three treatment arms. Patients will be randomized to one of the three following treatment arms:

Arm A: Radiation therapy in combination with vorinostat.

Arm B: Radiation Therapy in combination with temozolomide.

Arm C: Radiation therapy in combination with bevacizumab.

All treatment arms on this phase of the study will receive the same maintenance chemotherapy which will include the use of bevacizumab and temozolomide.

Phase 3 of this study will compare the 2 best treatments from Phase 2. People who are in Part 1 of this study will not be in Part 2 or 3. We are currently in the Phase I portion of this study.


Objectives


Eligibility


Contact

Alberto Broniscer, MD
St. Jude Children’s Research Hospital
262 Danny Thomas Place
Memphis, TN 38105 USA
901-595-2544 or 901-595-4925
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.