OncoMatch/Clinical Trials/NCT05052957
hSTAR GBM (Hematopoetic Stem Cell (HPC) Rescue for GBM)
Is NCT05052957 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments for glioblastoma multiforme.
Treatment: P140K-MGMT · O6-benzylguanine · temozolomide · Filgrastim · carmustine — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Glioblastoma
Biomarker criteria
Required: IDH1 wild-type
Required: IDH2 wild-type
Required: MGMT unmethylated
Performance status
ECOG OR KARNOFSKY 0–1
Prior therapy
Cannot have received: myelosuppressive chemotherapy
No myelosuppressive chemotherapy or hematopoietic cell transplantation prior to the diagnosis of GBM
Cannot have received: hematopoietic cell transplantation
No myelosuppressive chemotherapy or hematopoietic cell transplantation prior to the diagnosis of GBM
Cannot have received: chemotherapy (Gliadel BCNU wafers)
no prior chemotherapy (including Gliadel BCNU wafers) for GBM
Lab requirements
Blood counts
absolute neutrophil count (ANC) ≥ 1000/mm3, platelets ≥ 100,000/mm3, Hgb ≥ 9.5
Kidney function
serum creatinine ≤ 2.0 mg/dl or Creatinine Clearance ≥ 60mL/min/1.73 m2 for subjects with serum creatinine levels above institutional normal
Liver function
Bilirubin ≤ 2.0 mg/dl, AST and ALT ≤ 3x institutional upper limit of normal, prothrombin time <1.2 times normal
Adequate hematologic (absolute neutrophil count (ANC)≥ 1000/mm3, platelets ≥ 100,000/mm3, Hgb ≥ 9.5, hepatic (Bilirubin ≤ 2.0 mg/dl, AST and ALT less than or equal to 3 times institutional upper limit of normal, prothrombin time <1.2 times normal), and renal (serum creatinine ≤ 2.0 mg/dl or Creatinine Clearance ≥ 60mL/min/1.73 m2 for subjects with serum creatinine levels above institutional normal).
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University Hospitals Cleveland Medical Center · Cleveland, Ohio
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