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Phase 2
18 Years
N/A
Open (Enrolling)
Both
Glioma

Thank you

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 ClinicsMadison, Wisconsin  53792-0001