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

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

To determine the efficacy of Pulse Reduced Dose Rate (PRDR) radiation when given in 27 fraction over 5.5 weeks with concurrent bevacizumab followed by adjuvant bevacizumab until time of progression in patients with recurrent high grade gliomas (grade III and grade IV). Patients will be placed in 1 of 4 groups based on their histologic diagnosis and prior exposure to bevacizumab.

Inclusion Criteria:

• Histologically or molecularly confirmed Grade 3 or 4 glioma, IDH mutant or wildtype, as defined by the 2021 WHO guidelines
• Recurrent disease based on combination of clinical, imaging or histologic confirmation
• Must have previously received radiation and temozolomide to treat their glioma
• Bevacizumab naive patients must be > 5 months post completion of initial radiation therapy
• Bevacizumab exposed patients must be > 3 months post completion of initial radiation therapy
• Age must be >18years, KPS must be greater than 60
• Hematology, chemistry and a urinalysis must meet protocol specified criteria

Exclusion Criteria:

• Pregnant or breastfeeding
• Uncontrolled hypertension (>160/90mmHg)
• Prior malignancy unless treated >1 year prior to study and have been without treatment and disease free for 1 yr
• active second malignancy unless non-melanoma skin cancer or cervical cancer in situ