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Therapeutic Areas: Oncology
Disease Category: Gliomas

Trial Information

A Pilot Study of Temozolomide and 06Benzylguanine for Treatment of Newly Diagnosed High Grade Glioma, Using Autologous Peripheral Blood Stem Cells Genetically Modified for Chemoprotection

The Division of Hematology/Oncology at Cincinnati Children’s Hospital Medical Center would like to announce the opening of a new clinical trial for children and young adults who have been newly diagnosed with a type of brain tumor called high-grade glioma.

Who can participate?

• Patients must be between the ages of 5 years to 30 years, and
• must be newly diagnosed with a high-grade glioma (anaplastic astrocytoma, glioblastoma multiforme, or gliosarcoma).
• Only patients whose tumors could not be completely removed by surgery are eligible, and patients must have received no treatment other than surgery.

A total of 10 patients will be treated on this study.

Why is this study being done?
Cure rates for patients with high-grade glioma remain disappointing, in part because tumor cells are often resistant to chemotherapy, and because using higher doses of chemotherapy causes damage to normal blood cells. This trial is designed to try to overcome both of these barriers. Patients on this study will be treated with O6-Benzylguanine (BG), a drug which may help overcome resistance to temozolomide (TEM), one of the most commonly used drugs for this disease. In addition, patients will have a portion of their blood cells modified by the insertion of a chemotherapy resistance gene which will protect these blood cells from damage by the combination of TEM + BG.

The idea is to make tumor cells more sensitive to TEM by using BG, while making blood cells less sensitive to TEM + BG by using a “chemoprotection” gene inserted into blood cells. If successful, this approach may reduce the problem of low blood counts which is commonly seen when TEM + BG is used together, and may allow for higher doses of TEM + BG to be safely given. The purpose of this study is to determine the safety of modifying blood cells with this chemoprotection gene, and to determine whether higher doses of TEM combined with BG can safely be given.

What is involved?
Surgery, chemotherapy, and radiation therapy are standard methods for the treatment of brain tumors. All patients on this trial will have undergone surgery, and then will receive radiation combined with TEM, which is a standard approach to treating high-grade glioma. Prior to starting the radiation, blood cells will be collected from an IV (intravenous catheter) and frozen in the laboratory. After patients have recovered from radiation, the cells will be thawed, modified by insertion of the chemoprotection gene, and then reinfused back to the patient through an IV. Patients will then go on to receive 6 courses of TEM + BG. For patients who are tolerating the therapy well and who have the chemoprotection gene still present in the blood, higher doses of TEM + BG will be used. The total length of treatment is expected to last 10 months.

Patient safety is a priority for this trial. As described above, only patients who are not having severe side effects will receive higher doses of chemotherapy. Extra testing of the blood, as well as two bone marrow tests, will be performed to identify side effects of the chemoprotection gene insertion. In addition, patients are followed for up to 15 years after starting the study.

What are the benefits?
It is possible that there may not be any direct medical benefit. It is unknown whether this therapy is any better, worse, or the same as standard therapy for high-grade glioma. It is also possible that there may be benefit from the use of BG, or from receiving higher doses of TEM, if a patient qualifies to receive such higher doses.

What are the risks?
The risks associated with gene transfer are extensive and include the risk of infection, immune reaction, development of a new cancer, and death. The risks of BG could cause the side effects of TEM to be more severe. The risks of this study will be explained in detail with you before enrollment.

Will I be paid for participating in this study?
No. There is no monetary compensation for participation in this study.

Dr. Lars Wagner
Cincinnati Children's Hospital Medical Center/Cincinnati Children's Research Foundation
Hematology/Oncology Department, MLC 7015
3333 Burnet Avenue
Cincinnati OH 45229-3039
Phone: 513-636-1849 or 1-800-344-2462 (toll free)
EMail: lars.wagner@cchmc.org

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