Multiple Intracerebral Doses of Neural Stem Cell-Based Virotherapy (NSC-CRAd-S-pk7) for the Treat… (NCT05139056) | Clinical Trial Compass
SuspendedPhase 1
Multiple Intracerebral Doses of Neural Stem Cell-Based Virotherapy (NSC-CRAd-S-pk7) for the Treatment of Recurrent High-Grade Gliomas
Stopped: Safety issues
United States36 participantsStarted 2023-05-02
Plain-language summary
This phase I trial studies the safety of giving multiple intracerebral doses of NSC-CRAd-S-pk7 to treat patients with glioblastoma at first recurrence. NSC-CRAd-S-pk7 consists of neural stem cells that can target glioblastoma cells and carry a virus, which can kill cancer cells. Giving multiple doses of NSC-CRAd-S-pk7 may kill more tumor cells.
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:
* Patient must be age \>= 18 years
* Patient has a Karnofsky performance status of \>= 70%
* Patient has a life expectancy of \>= 3 months
* When determining the maximum tolerated number of treatment cycles (MTC): patient has a histologically confirmed diagnosis of a grade 3 or 4 glioma (eg., glioblastoma, grade 4 astrocytoma, grade 3 astrocytoma, grade 3 oligodendroglioma). (This part of the study has been completed).
* When enrolling to Treatment Schedules 4 and 4a: patient has glioblastoma at first recurrence.
* Imaging studies show evidence of recurrent, supratentorial tumor(s).
* Patient's high-grade glioma has recurred or progressed after prior treatment with brain radiation and temozolomide
* The patient must be in need of surgery for tumor resection
* Based on the neurosurgeon's judgment, there is no anticipated physical connection between the post-resection tumor cavity and the cerebral ventricles
* Absolute neutrophil count (ANC) of \>= 1000 cells/mm\^3
* Platelet count \>= 100,000 cells/mm\^3
* Total bilirubin =\< 2.0 mg/dl
* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\]) =\< 4 times the institutional upper limit of normal
* Serum creatinine =\< the institutional upper limit of normal
* At least 2 weeks from taking the last dose of a targeted agent
* At least 4 weeks from the last dose of bevacizumab For temozolomide, an interval of 23 days is required from the last dose administered if the patient was …
What they're measuring
1
Incidence of adverse events
Timeframe: Up to 30 days post removal of Rickhams
2
Progression-free survival (PFS)
Timeframe: From the time of surgery to the event date of progression, assessed at 6 months]