Clinical Trials /

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

NCT01743950

Description:

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.

Related Conditions:
  • Malignant Glioma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: A Phase II Study of Pulse Reduced Dose Rate Radiation Therapy With Bevacizumab
  • Official Title: A Phase II Study of Pulse Reduced Dose Rate Radiation Therapy With Bevacizumab

Clinical Trial IDs

  • ORG STUDY ID: CO11374
  • SECONDARY ID: P30CA014520
  • SECONDARY ID: NCI-2012-02775
  • SECONDARY ID: 2012-0648
  • SECONDARY ID: 2017-0683
  • NCT ID: NCT01743950

Conditions

  • Glioma

Interventions

DrugSynonymsArms
BevacizumabBevacizumab naive recurrent grade IV gliomas

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.

Trial Arms

NameTypeDescriptionInterventions
Bevacizumab naive recurrent grade IV gliomasActive Comparator27fractions over 5.5weeks of PRDR radiation with bevacizumab followed by adjuvant bevacizumab until time of progression
  • Bevacizumab
Bevacuzumab exposed and refractive grade IV gliomasActive Comparator27fractions over 5.5weeks of PRDR radiation with bevacizumab followed by adjuvant bevacizumab until time of progression
  • Bevacizumab
Bevacizumab naive recurrent grade III gliomasActive Comparator27fractions over 5.5weeks of PRDR radiation with bevacizumab followed by adjuvant bevacizumab until time of progression
  • Bevacizumab
Bevacizumab exposed and refractive grade III gliomasActive Comparator27fractions over 5.5weeks of PRDR radiation with bevacizumab followed by adjuvant bevacizumab until time of progression
  • Bevacizumab

Eligibility 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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Overall survival
Time Frame:end of study, which will be an average of 12 months
Safety Issue:
Description:time of first dose of PDRD+ Bevacizumab until time of death

Secondary Outcome Measures

Measure:safety profile
Time Frame:assessed every two weeks prior to each bevacizumab infusion while on treatment then 30 post completion of therapy
Safety Issue:
Description: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.
Measure:progression free survival
Time Frame:at 3months for bevacizumab exposed patients, at 6 and 12 months for all patients
Safety Issue:
Description:will be determined based on clinical and radiographic evidence
Measure:neurologic changes
Time Frame:baseline and then approximately every 8 weeks for 18 months
Safety Issue:
Description:will be assessed by physician with mini-mental exam and a FACT BR completed by the patient

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:University of Wisconsin, Madison

Trial Keywords

  • Glioblastoma
  • anaplastic glioma

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