OncoMatch/Clinical Trials/NCT05052957
hSTAR GBM (Hematopoetic Stem Cell (HPC) Rescue for GBM)
Official title: Phase II Trial O6-benzylguanine(BG) and Temozolomide(TMZ) Therapy of Glioblastoma Multiforme (GBM) With Infusion of Autologous P140K MGMT+Hematopoietic Progenitors to Protect Hematopoiesis
Is NCT05052957 recruiting? Yes, currently enrolling (Oct 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 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: malignant disease
Exception: non-melanomatous skin cancer, or carcinoma in situ of the cervix, bladder, prostate, or breast, or disease-free/in remission for ≥2 years prior to date of study enrollment
Prior diagnosis of any malignant disease with the exception of non-melanomatous skin cancer, or carcinoma in situ of the cervix, bladder, prostate, or breast, unless the participant has been disease-free/in remission for ≥2 years prior to date of study enrollment.
Lab requirements
Blood counts
ANC ≥ 1,000 cells/mm3 (G-CSF/intervention allowed); Platelets ≥ 50,000 cells/mm3 (transfusion/intervention allowed); Hemoglobin ≥ 9.0 g/dl (transfusion/intervention allowed)
Liver function
Bilirubin ≤ 3 ULN; ALT and AST ≤ 3 x ULN
Cardiac function
No diagnosis of heart failure or cardiac insufficiency and LVEF < 40%
Adequate hematologic and hepatic function: ... Bilirubin ≤ 3 ULN; ALT and AST ≤ 3 x ULN; ANC ≥ 1,000 cells/mm3; Platelets ≥ 50,000 cells/mm3; Hemoglobin ≥ 9.0 g/dl. Participants with known diagnosis heart failure or cardiac insufficiency and an LVEF of < 40% [excluded].
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.
Are there prior therapy exclusions?
Yes. Prior malignant disease disqualifies patients from enrollment.
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.
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