VB-111 in Surgically Accessible Recurrent/Progressive GBM
Stopped: Trial stopped at request of VBL Therapeutics, as they are no longer pursuing their VB-111 development program.
United States15 participantsStarted 2020-08-01
Plain-language summary
This research study is studying a new viral cancer therapy, ofranergene obadenovec (VB-111), for recurrent or progressive glioblastoma (GBM), a brain tumor that is growing or progressing despite earlier treatment.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria: ° ± µ ™ ®
* Histologically confirmed World Health Organization Grade IV malignant glioma (glioblastoma or gliosarcoma).
* First or second progression of glioblastoma/gliosarcoma (according to RANO criteria) following standard of care treatment upon initial diagnosis with radiation.
* Measurable disease by RANO criteria at progression.
* The maximal tumor volume at baseline meets the following criteria as determined by a local site investigator or surgeon: Longest diameter ≤ 4CM.
* Surgically resectable disease at progression.
* An interval of the following durations prior to randomization:
* At least 28 days from prior surgical resection, or 7 days from stereotactic biopsy
* At least 12 weeks from prior radiotherapy, unless there is unequivocal histologic confirmation of tumor progression
* At least 23 days from prior chemotherapy
* At least 42 days from nitrosureas
* At least 42 days from other anti-tumor therapies (including vaccines)
* At least 28 days from any investigational agent NOTE: no wash-out period required from TTF.
* Participants must have recovered to grade 0 or 1 or pre-treatment baseline from clinically significant toxic effects of prior therapy (including but not limited to exceptions of alopecia, laboratory values listed per inclusion criteria, and lymphopenia which is common after therapy with temozolomide.
* Corticosteroid use at or less than dexamethasone 2mg daily. Participants should be on a stable or decreasing dose f…
What they're measuring
1
Tumor Infiltrating T Cell (TIL) Density
Timeframe: 2 years
2
# of Participants to Experience a Reportable SAE on Study