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

• Status: Recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Wisconsin, Madison
• Collaborators: Genentech, Inc.; National Cancer Institute (NCI)
• Treatments: Bevacizumab

Criteria

Inclusion Criteria:

• Histologically confirmed diagnose of a grade WHO grade III or IV glioma

• 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 > 6months post completion of initial radiation therapy

• Bevacizumab exposed patients must be > 3months 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

• May not be on full dose anti-coagulation therapy, Low molecular weight heparin is ok

• Uncontrolled hypertension (>140/90mmHg)

• 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