OncoMatch/Clinical Trials/NCT05052957
hSTAR GBM (Hematopoetic Stem Cell (HPC) Rescue for GBM)
Is NCT05052957 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Chemotherapy
Other
Cancer type
Glioblastoma
Biomarker criteria
Required: IDH1 wild-type
Required: IDH2 wild-type
Required: MGMT unmethylated
Performance status
ECOG OR KARNOFSKY 0–1
Demographics
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
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT05052957 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require IDH1?
Yes, IDH1 wild-type is a required biomarker for enrollment.
Does this trial require IDH2?
Yes, IDH2 wild-type is a required biomarker for enrollment.
Does this trial require MGMT?
Yes, MGMT unmethylated is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 75 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages