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hSTAR GBM (Hematopoetic Stem Cell (HPC) Rescue for GBM)
NCT05052957 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- DRUG Filgrastim
- BIOLOGICAL P140K-MGMT
- DRUG O6-benzylguanine
- RADIATION Photon Based Radiotherapy
- DRUG temozolomide
Study Locations (1)
Ohio
- University Hospitals Cleveland Medical Center — Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2023-01-20 |
| Est. Completion | 2026-12-01 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05052957
The ClinicalTrials.gov registry entry for NCT05052957 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Leland Metheny, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 4 conditions, with Glioblastoma Multiforme appearing as the primary indexed condition, and to 5 interventions — of which Filgrastim is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05052957 reports 1 study location spanning 1 distinct geographic area — top geographies include Ohio. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05052957 about?
NCT05052957 is a clinical study titled "hSTAR GBM (Hematopoetic Stem Cell (HPC) Rescue for GBM)". 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...
What is the current status of trial NCT05052957?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 16 participants. The study started on 2023-01-20. Estimated completion is 2026-12-01.
What conditions does trial NCT05052957 study?
This clinical trial studies the following conditions: Glioblastoma Multiforme, Glioblastoma Multiforme, Adult, Supratentorial Glioblastoma, Supratentorial Gliosarcoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05052957?
The interventions under investigation include: Filgrastim (DRUG), P140K-MGMT (BIOLOGICAL), O6-benzylguanine (DRUG), Photon Based Radiotherapy (RADIATION), temozolomide (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05052957?
This trial is sponsored by Leland Metheny, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05052957 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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