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NCT05052957 · ClinicalTrials.gov registry record · Phase 2
hSTAR GBM (Hematopoetic Stem Cell (HPC) Rescue for GBM)
A Phase 2 study of Glioblastoma Multiforme and Glioblastoma Multiforme, Adult, sponsored by Leland Metheny.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 16
- Enrollment target
- 1
- Study location
NCT05052957 is a Phase 2 study of Glioblastoma Multiforme and Glioblastoma Multiforme, Adult that is actively recruiting participants, run by Leland Metheny. The registered enrollment target is 16 participants, below the 97-participant average among 88 other Glioblastoma Multiforme trials with a reported enrollment target (84% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05052957, a Phase 2 study of Glioblastoma Multiforme and Glioblastoma Multiforme, Adult, is actively recruiting participants, sponsored by Leland Metheny.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 16 participants
- Enrollment target
- 1
- Study location
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, categorized as Phase 2. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 97-participant average among 88 other Glioblastoma Multiforme trials with a reported enrollment target (84% lower). The listed sponsor is Leland Metheny, which has 3 total studies on file at ClinicalTrials.gov.
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.
NCT05052957 reports 1 study location spanning 1 distinct geographic area - top geographies include Ohio.
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.
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).
Who is sponsoring clinical trial NCT05052957?
This trial is sponsored by Leland Metheny, which has 3 total clinical trials registered on ClinicalTrials.gov.
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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