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Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Relapsed Glioblastoma Multiforme

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Trial Information


Inclusion Criteria:



1. Subjects must have a histologically confirmed diagnosis of glioblastoma multiforme or
gliosarcoma;

2. Measurable disease by RANO criteria;

3. Disease progression or recurrence following standard of care treatment with
temozolomide and radiation;

4. An interval of at least 4 weeks between prior surgical resection and study
enrollment;

5. An interval of at least 12 weeks between prior radiotherapy or at least 4 weeks from
prior chemotherapy, and enrollment in this protocol;

6. Recovered to Grade 1 or less from the toxic effects of any earlier intervention;

7. Karnofsky performance status > 60%

Exclusion Criteria:

1. Prior anti-angiogenic therapy including VEGF sequestering agents (ie bevacizumab,
aflibercept, etc) or VEGFR inhibitors (cedirinib, pazopanib, sunitinib, sorafenib,
etc);

2. Prior stereotactic radiotherapy;

3. Active infection;

4. Evidence of CNS haemorrhage CTCAE grade 2 or above on baseline MRI;

5. Requires therapeutic anti-coagulation;

6. Subjects who suffered from an acute cardiac event within the last 12 months;

7. Subjects with active vascular disease, either myocardial or peripheral;

8. Subjects with proliferative and/or vascular retinopathy;

9. Subjects with known active second malignancy;

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Authority:

United States: Food and Drug Administration

Study ID:

VB-111-122

NCT ID:

NCT01260506

Start Date:

December 2010

Completion Date:

Related Keywords:

  • Relapsed Glioblastoma Multiforme
  • Relapsed Glioblastoma Multiforme, GBM
  • Glioblastoma

Name

Location

Duke University Medical CenterDurham, North Carolina  27710
Dana Farber Cancer InstituteBoston, Massachusetts  02115
Uthsc- CtrcSan Antonio, Texas