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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01743950
Recruitment Status : Recruiting
First Posted : December 6, 2012
Last Update Posted : October 8, 2020
Sponsor:
Collaborators:
Genentech, Inc.
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Wisconsin, Madison

Brief 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.

Condition or disease Intervention/treatment Phase
Glioma Drug: Bevacizumab Radiation: PRDR Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Pulse Reduced Dose Rate Radiation Therapy With Bevacizumab
Actual Study Start Date : December 3, 2012
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Bevacizumab

Arm Intervention/treatment
Active Comparator: Bevacizumab naive recurrent grade IV gliomas
27fractions over 5.5weeks of PRDR radiation with bevacizumab followed by adjuvant bevacizumab until time of progression
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.
Other Name: re-irradiation

Active Comparator: Bevacuzumab exposed and refractive grade IV gliomas
27fractions over 5.5weeks of PRDR radiation with bevacizumab followed by adjuvant bevacizumab until time of progression
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.
Other Name: re-irradiation

Active Comparator: Bevacizumab naive recurrent grade III gliomas
27fractions over 5.5weeks of PRDR radiation with bevacizumab followed by adjuvant bevacizumab until time of progression
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.
Other Name: re-irradiation

Active Comparator: Bevacizumab exposed and refractive grade III gliomas
27fractions over 5.5weeks of PRDR radiation with bevacizumab followed by adjuvant bevacizumab until time of progression
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.
Other Name: re-irradiation




Primary Outcome Measures :
  1. Overall survival [ Time Frame: end of study, which will be an average of 12 months ]
    time of first dose of PDRD+ Bevacizumab until time of death


Secondary Outcome Measures :
  1. Incidence of Adverse Events [ Time Frame: up to 30 days post last dose of bevacizumab ]
    time of first dose of PDRD+ Bevacizumab until time of death. All changes from baseline assessment will be recorded until 30 days post last dose of bevacizumab, assessed using the NCI CTCAE version 4.0 criteria.

  2. Incidence of Late Toxicities [ Time Frame: from 90 days post radiotherapy until time of death ]
    Late toxicity that is likely attributable to re-irradiation or bevacizumab will be recorded.

  3. progression free survival [ Time Frame: at 3 months for bevacizumab exposed patients, at 6 and 12 months for all patients ]
    Progression free survival (PFS) will be defined as the time from the first study treatment to the first occurrence of disease progression or death.

  4. Change in Mini Mental State Exam (MMSE) Score [ Time Frame: baseline and then approximately every 8 weeks for 18 months ]
    The MMSE survey is a clinician facilitated instrument scored on a scale of 0-30 where scores of 0-17 indicate severe cognitive impairment, 18-23 indicate mild cognitive impairment, and 24-30 indicate no cognitive impairment.

  5. Change in Participant Reported FACT-BR Score [ Time Frame: baseline and then approximately every 8 weeks for 18 months ]
    The Functional Assessment of Cancer Therapy - Brain (FACT-BR) instrument is a 50-item survey with each item scored on a 5 point likert scale where 0 is 'not at all' and 4 is 'very much'. The total possible range of scores is 0-200 where higher scores indicate higher quality of life.

  6. Change in Participant Reported FACIT-F Score [ Time Frame: baseline and then approximately every 8 weeks for 18 months ]
    The Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) instrument is a 13-item survey with each item scored on a 5 point likert scale where 0 is 'not at all' and 4 is 'very much'. The total possible range of scores is from 0-52 where higher scores indicate better quality of life. A score of less than 30 indicates severe fatigue.

  7. Change in Karnofsky Performance Status [ Time Frame: baseline and then approximately every 8 weeks for 18 months ]
    The Karnofsky Performance Status measures a cancer patient's ability to perform ordinary tasks. It is score from 0-100 where 0 means a person has died, less than 40 is various degrees of unable to care for oneself, 50-70 is unable to work but can care for personal needs with variable assistance, and 80-100 is able to carry on normal activity with variable symptoms of disease.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01743950


Contacts
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Contact: Diana Trask, BS 608-263-9528 trask@humonc.wisc.edu
Contact: Nick Anger, BS 608-262-8649 anger@humonc.wisc.edu

Locations
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United States, Wisconsin
University of Wisconsin Hospital and Clinics Recruiting
Madison, Wisconsin, United States, 53792
Contact: Cancer Connect    800-622-8922    clinicaltrials@cancer.wisc.edu   
Principal Investigator: Steve Howard, MD         
Principal Investigator: H. Ian Robins, MD, Ph.D         
Sponsors and Collaborators
University of Wisconsin, Madison
Genentech, Inc.
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Steve Howard, MD University of Wisconsin, Madison
Principal Investigator: H. Ian Robins, MD, Ph.D University of Wisconsin, Madison
Additional Information:
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Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT01743950    
Other Study ID Numbers: CO11374
NCI-2012-02775 ( Registry Identifier: NCI Trial ID )
2012-0648 ( Other Identifier: Institutional Review Board )
2017-0683 ( Other Identifier: Institutional Review Board )
A533300 ( Other Identifier: UW Madison )
SMPH\HUMAN ONCOLOGY\HUMAN ONCO ( Other Identifier: UW Madison )
Protocol Version 1/8/2020 ( Other Identifier: UW Madison )
First Posted: December 6, 2012    Key Record Dates
Last Update Posted: October 8, 2020
Last Verified: October 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by University of Wisconsin, Madison:
Glioblastoma
anaplastic glioma
Additional relevant MeSH terms:
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Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Bevacizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors