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

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ClinicalTrials.gov Identifier: NCT01743950
Recruitment Status : Recruiting
First Posted : December 6, 2012
Last Update Posted : June 5, 2019
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
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
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
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
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. safety profile [ Time Frame: assessed every two weeks prior to each bevacizumab infusion while on treatment then 30 post completion of therapy ]
    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. In addition any late toxicity that is likely attributable to re-irradiation or bevacizumab will be recorded.

  2. progression free survival [ Time Frame: at 3months for bevacizumab exposed patients, at 6 and 12 months for all patients ]
    will be determined based on clinical and radiographic evidence

  3. neurologic changes [ Time Frame: baseline and then approximately every 8 weeks for 18 months ]
    will be assessed by physician with mini-mental exam and a FACT BR completed by the patient



Information from the National Library of Medicine

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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
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

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Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT01743950     History of Changes
Other Study ID Numbers: CO11374
P30CA014520 ( U.S. NIH Grant/Contract )
NCI-2012-02775 ( Registry Identifier: CTRP )
2012-0648 ( Other Identifier: Institutional Review Board )
2017-0683 ( Other Identifier: Institutional Review Board )
First Posted: December 6, 2012    Key Record Dates
Last Update Posted: June 5, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

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