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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT01743950
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 University of Wisconsin, Madison
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Steve Howard, MDH. Ian Robins, MD, Ph.D
Principal Investigator Affiliation University of Wisconsin, MadisonUniversity of Wisconsin, Madison
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other, Industry, NIH
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Glioma
Study Website: View Trial Website
Arms & Interventions

Arms

Active Comparator: 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

Active Comparator: 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

Active Comparator: Bevacizumab-naïve with recurrent IDH mutant glioma

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

Active Comparator: Bevacizumab-exposed with recurrent IDH mutant glioma

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

Interventions

Drug: - Bevacizumab

10mg/kg every 2weeks.

Radiation: - 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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Madison, Wisconsin

Status

Recruiting

Address

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, 53792

Site Contact

Cancer Connect

clinicaltrials@cancer.wisc.edu

800-622-8922

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