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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: Recruiting Phase 2 study of Glioblastoma Multiforme and Glioblastoma Multiforme, Adult, sponsored by Leland Metheny.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
To evaluate and compare the feasibility of introducing and expressing P140K MGMT cDNA using a lentiviral-based provirus in autologous hematopoietic stem cells harvested from newly diagnosed IDH-1 WT GBM with unmethylated MGMT promoter using two different sequences of stem cell mobilization. 1\. What percent of patients who enter trial can complete treatment.
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 |
What NCT05052957 shows while recruiting
NCT05052957 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 97-participant average among 88 other Glioblastoma Multiforme trials with a reported enrollment target (84% lower).
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 a single indexed study location in 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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Where NCT05052957's enrollment target sits among peer trials
16 73rd of 88 higher than 14 of 88 other Glioblastoma Multiforme trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Glioblastoma Multiforme trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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