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

University of Wisconsin (UW)

Status and phase: Terminated; Phase 2

Conditions: Glioma

Treatments: Drug: Bevacizumab; Radiation: PRDR

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT01743950

2012-0648 (Other Identifier)

Protocol Version 10/14/2020 (Other Identifier)

A533300 (Other Identifier)

2017-0683 (Other Identifier)

SMPH\HUMAN ONCOLOGY\HUMAN ONCO (Other Identifier)

CO11374

NCI-2012-02775 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 49 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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49 participants in 4 patient groups

Bevacizumab-naïve with recurrent IDH wildtype high grade glioma

Active Comparator group

Description:

27fractions over 5.5weeks of PRDR radiation with bevacizumab followed by adjuvant bevacizumab until time of progression

Treatment:

Radiation: PRDR

Drug: Bevacizumab

Bevacizumab-exposed with refractory recurrent IDH wildtype high grade glioma

Active Comparator group

Description:

27fractions over 5.5weeks of PRDR radiation with bevacizumab followed by adjuvant bevacizumab until time of progression

Treatment:

Radiation: PRDR

Drug: Bevacizumab

Bevacizumab-naïve with recurrent IDH mutant glioma

Active Comparator group

Description:

27fractions over 5.5weeks of PRDR radiation with bevacizumab followed by adjuvant bevacizumab until time of progression

Treatment:

Radiation: PRDR

Drug: Bevacizumab

Bevacizumab-exposed with recurrent IDH mutant glioma

Active Comparator group

Description:

27fractions over 5.5weeks of PRDR radiation with bevacizumab followed by adjuvant bevacizumab until time of progression

Treatment:

Radiation: PRDR

Drug: Bevacizumab