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hSTAR GBM (Hematopoetic Stem Cell (HPC) Rescue for GBM)

Study acronym: hSTAR GBM
StatusRecruiting
PhasePhase 2
Started2023-01-20
View on ClinicalTrials.gov ↗
This phase II trial studies the effect of P140K MGMT hematopoietic stem cells, O6-benzylguanine, temozolomide, and carmustine in treating participants with supratentorial glioblastoma or gliosarcoma who have recently had surgery to remove most or all of the brain tumor (resected). Chemotherapy drugs, such as 6-benzylguanine, temozolomide, and carmustine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing. Placing P140K MGMT, a gene that has been created in the laboratory into bone marrow making the bone more resistant to chemotherapy, allowing intra-patient dose escalation which kills more tumor cells while allowing bone marrow to survive.

Amendment history 2 changes detected by DataLookout

2026-09-11
notable
Primary completion pushed: 2026-06-01 → 2026-11-01
2026-09-11
minor
Completion pushed: 2026-12-01 → 2027-03-01
Trial Details
NCT Number NCT05052957
Lead Sponsor Leland Metheny
Collaborators: National Cancer Institute (NCI)
Conditions Glioblastoma Multiforme, Glioblastoma Multiforme, Adult, Supratentorial Glioblastoma, Supratentorial Gliosarcoma
Enrollment 16 participants
Start Date 2023-01-20
Primary Completion 2026-11-01 (estimated)
Study Completion 2027-03-01 (estimated)
Updated on ClinicalTrials.gov 2026-09-10