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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-03

Study Completion Date

2024-12-24

Brief Summary

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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.

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Detailed Description

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Conditions

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Glioma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Bevacizumab-naïve with recurrent IDH wildtype high grade glioma

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

Group Type ACTIVE_COMPARATOR

Bevacizumab

Intervention Type DRUG

10mg/kg every 2weeks.

PRDR

Intervention Type RADIATION

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.

Bevacizumab-exposed with refractory recurrent IDH wildtype high grade glioma

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

Group Type ACTIVE_COMPARATOR

Bevacizumab

Intervention Type DRUG

10mg/kg every 2weeks.

PRDR

Intervention Type RADIATION

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.

Bevacizumab-naïve with recurrent IDH mutant glioma

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

Group Type ACTIVE_COMPARATOR

Bevacizumab

Intervention Type DRUG

10mg/kg every 2weeks.

PRDR

Intervention Type RADIATION

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.

Bevacizumab-exposed with recurrent IDH mutant glioma

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

Group Type ACTIVE_COMPARATOR

Bevacizumab

Intervention Type DRUG

10mg/kg every 2weeks.

PRDR

Intervention Type RADIATION

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.

Interventions

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Bevacizumab

10mg/kg every 2weeks.

Intervention Type DRUG

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.

Intervention Type RADIATION

Other Intervention Names

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re-irradiation

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No