Single-Arm Open-Label Multicenter Study of VB-111 in Patients With Recurrent Glioblastoma Multiforme
This trial is active, not recruiting.
|Phase||phase 1/phase 2|
|Sponsor||Vascular Biogenics Ltd. operating as VBL Therapeutics|
|Start date||December 2010|
|End date||December 2015|
|Trial size||75 participants|
|Trial identifier||NCT01260506, VB-111-122|
The purpose of this study is to evaluate the safety, tolerability and efficacy of VB-111 in patients with Relapsed Glioblastoma Multiforme.
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
|Boston, MA||Dana Farber Cancer Institute||no longer recruiting|
|Durham, NC||Duke University Medical Center||no longer recruiting|
|San Antonio, TX||Uthsc- Ctrc||no longer recruiting|
|Tel Aviv, Israel||Tel Aviv Sourasky Medical Center||no longer recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
Antiangiogenic and vascular disruptive agent
time frame: From date of study entry until the date of death from any cause (up to 10 years)
Progression Free Survival
time frame: 6 months
Male or female participants at least 18 years old.
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;
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