Phase 2
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Both
Glioma
Both
Glioma
Trial Information
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Overall survival
Outcome Description:
time of first dose of PDRD+ Bevacizumab until time of death
Outcome Time Frame:
end of study, which will be an average of 12 months
Safety Issue:
No
Principal Investigator
Steve Howard, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of Wisconsin, Madison
Authority:
United States: Food and Drug Administration
Study ID:
CO11374
NCT ID:
NCT01743950
Start Date:
December 2012
Completion Date:
December 2018
Related Keywords:
- Glioma
- Glioblastoma
- anaplastic glioma
- Glioma
Name | Location |
|---|---|
| University of Wisconsin Hospital and Clinics | Madison, Wisconsin 53792-0001 |
