Subjects are being asked to volunteer for a research study because they have their first anaplastic astrocytoma (AA) tumor progression (worsening) or recurrence.
The purpose of this study is to measure how well and how safe eflornithine is in combination with lomustine, compared to lomustine taken alone, in treating patients whose anaplastic astrocytoma has come back after radiation and chemotherapy. Eflornithine is an experimental drug that the United States Food and Drug Administration (FDA) has not approved it for use by the general public. Lomustine has been approved by the FDA in the United States for this patient population.
The purpose of this study is to determine if the investigational products, Toca 511 and Toca FC, as a combination treatment is effective (works) and safe, compared to a selected number of approved treatments for brain tumors, called a control treatment. Toca 511 is a live virus that has been built to carry a gene into cancer cells. This gene carries instructions that cause the cancer cells to turn Toca FC into a drug that may kill the cancer cells. Toca FC is an investigational extended-release form of flucytosine (5-FC). Flucytosine is a drug approved to treat fungal infections; however, it is not approved for the treatment of brain tumors. This study will examine whether your tumor grows back after surgery and treatment with either Toca 511 and Toca FC combination treatment or the control treatment, and whether you will live longer.
This study is for patients with a low grade glioma (a slow growing tumor in the brain). The purpose of this study is to compare the effects, good and/or bad, of adding the chemotherapy pill temozolomide to radiation. Temozolomide is an experimental drug for low-grade gliomas. Patients will be randomly assigned to 1 of 2 groups. One group will receive radiation alone, while the other group receives Temozolomide chemotherapy in addition to the radiation. Patients will receive radiation for 5.5 weeks; patients may also take temozolomide during the 5.5 weeks of radiation and for up to one year thereafter. Follow-up exams will occur every 3 months for 15 years.