Clinical trial

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

Name

CO11374

Description

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.

Trial arms

Trial start

2012-12-03

Estimated PCD

2024-12-01

Trial end

2025-12-01

Status

Active (not recruiting)

Phase

Early phase I

Treatment

Bevacizumab

10mg/kg every 2weeks.

Arms:

Bevacizumab-exposed with recurrent IDH mutant glioma, Bevacizumab-exposed with refractory recurrent IDH wildtype high grade glioma, Bevacizumab-naïve with recurrent IDH mutant glioma, Bevacizumab-naïve with recurrent IDH wildtype high grade glioma

PRDR

Daily dose of 2.0gy delivered in .2gy pulses for a total of 54gy over 5.5 weeks and 27 fractions. In the rare instance of the presence of extensive disease requiring essentially whole brain radiation, a total daily dose of 1.8 Gy delivered in .2 Gy pulses for 23 fractions to a total dose of 41.4 Gy will be utilized.

Arms:

Other names:

re-irradiation

Size

Primary endpoint

Overall survival

end of study, which will be an average of 12 months

Eligibility criteria

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 49, 'type': 'ACTUAL'}}

Updated at

2024-05-02

1 organization

1 drug

1 indication

Organization

University of Wisconsin, Madison

Drug

Atezolizumab

Indication

Glioma