Single-Arm Open-Label Multicenter Study of VB-111 in Patients With Recurrent Glioblastoma Multiforme
Status: | Unknown status |
---|---|
Conditions: | Brain Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 10/25/2018 |
Start Date: | December 2010 |
The purpose of this study is to evaluate the safety, tolerability and efficacy of VB-111 in
patients with Relapsed Glioblastoma Multiforme.
patients with Relapsed Glioblastoma Multiforme.
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 (cediranib, 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. Subjects who suffered from an acute cardiac event within the last 12 months;
6. Subjects with active vascular disease, either myocardial or peripheral;
7. Subjects with proliferative and/or vascular retinopathy;
8. Subjects with known active second malignancy;
We found this trial at
4
sites
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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