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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by University of Wisconsin, Madison
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT01743950
First received: November 27, 2012
Last updated: February 25, 2014
Last verified: February 2014
  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.


Condition Intervention Phase
Glioma
Drug: Bevacizumab
Radiation: PRDR
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • Overall survival [ Time Frame: end of study, which will be an average of 12 months ] [ Designated as safety issue: No ]
    time of first dose of PDRD+ Bevacizumab until time of death


Secondary Outcome Measures:
  • safety profile [ Time Frame: assessed every two weeks prior to each bevacizumab infusion while on treatment then 30 post completion of therapy ] [ Designated as safety issue: Yes ]
    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.

  • progression free survival [ Time Frame: at 3months for bevacizumab exposed patients, at 6 and 12 months for all patients ] [ Designated as safety issue: No ]
    will be determined based on clinical and radiographic evidence

  • neurologic changes [ Time Frame: baseline and then approximately every 8 weeks for 18 months ] [ Designated as safety issue: No ]
    will be assessed by physician with mini-mental exam and a FACT BR completed by the patient


Estimated Enrollment: 80
Study Start Date: December 2012
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01743950

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

Locations
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.
Investigators
Principal Investigator: Steve Howard, MD University of Wisconsin, Madison
Principal Investigator: H. Ian Robins, MD, Ph.D University of Wisconsin, Madison
  More Information

No publications provided

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT01743950     History of Changes
Other Study ID Numbers: CO11374
Study First Received: November 27, 2012
Last Updated: February 25, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Wisconsin, Madison:
Glioblastoma
anaplastic glioma

Additional relevant MeSH terms:
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antineoplastic Agents
Growth Inhibitors
Growth Substances
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014