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Protocol No. CO11374

Principal Investigator Howard, Steven

Phase II

Age Group Adult

Scope Local

Sponsor Type Institutional

Title A Phase II Study of Pulse Reduced Dose Rate Radiation Therapy with Bevacizumab

Objective The purpose of this study is to find out what effects (good and bad) the combination of Pulsed Reduced Dose Rate Radiation (PRDR) and bevacizumab have on brain tumors (glioblastoma, anaplastic astrocytoma, anaplastic oligodendroglioma, mixed anaplastic oligoastrocytoma), which have grown or recurred. This research is being done because these types of tumors are almost never cured with surgery, radiation, or chemotherapy. For this reason, we are trying to find new ways to improve treatment for tumors that recur.

Treatment PRDR is a radiation delivery technique that slowly delivers radiation to the tumor over a period of approximately 45-60 minutes each day of treatment. The goal of this technique is to reduce toxicity to normal brain tissue around the tumor, while delivering a high dose of radiation to the tumor. Radiation will last 5.5 weeks.

Bevacizumab is an FDA-approved drug approved for use in recurrent brain tumors. Bevacizumab blocks the VEGF (Vascular Endothelial Growth Factor) protein that is produced by normal cells and overproduced by cancer cells.

Description In this study all participants will receive an additional 27 radiation treatments using a technique called Pulsed Reduced Dose Rate Radiation (PRDR) in combination with a drug called Bevacizumab. Click here for more info

Key Eligibility
  • Patients must have a confirmed diagosis of glioblastoma or anaplastic glioma, WHO grade 3 or 4.
  • Patients must have been previously treated with radiation therapy and temozolomide or radiation therapy, temozolomide and bevacizumab. Therapy with these agents may be given together or sequentially in the past.
  • All patients may have had prior surgery, chemotherapy and radiation therapy.
  • Patients may not be on full dose anit-coagulation therapy. Maintenance doses of low molecular weight heparin is permissible.
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    Applicable Disease Sites Brain/Central Nervous System

    Therapies Involved Other; Radiotherapy

    Drugs Involved Avastin (bevacizumab); bevacizumab; rhu Mab VEGF (bevacizumab)

    Status Open

    Participating Institutions Aspirus UW Cancer Center (formerly Riverview Hospital); Aspirus Wausau Hospital, Aspirus Regional Cancer Center; UW Hospital and Clinics