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NCT05106296 · ClinicalTrials.gov registry record · Phase 1
Chemo-immunotherapy Using Ibrutinib Plus Indoximod for Patients With Pediatric Brain Cancer
A Phase 1 study of Glioblastoma and Medulloblastoma, sponsored by Theodore S. Johnson.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 37
- Enrollment target
- 1
- Study location
NCT05106296: Recruiting Phase 1 study of Glioblastoma and Medulloblastoma, sponsored by Theodore S. Johnson.
NCT05106296 is a Phase 1 study of Glioblastoma and Medulloblastoma that is actively recruiting participants, run by Theodore S. Johnson. The registered enrollment target is 37 participants, below the 109-participant average among 199 other Glioblastoma trials with a reported enrollment target (66% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05106296, a Phase 1 study of Glioblastoma and Medulloblastoma, is actively recruiting participants, sponsored by Theodore S. Johnson.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 37 participants
- Enrollment target
- 1
- Study location
Study Summary
Recent lab-based discoveries suggest that IDO (indoleamine 2,3-dioxygenase) and BTK (Bruton's tyrosine Kinase) form a closely linked metabolic checkpoint in tumor-associated antigen-presenting cells. The central clinical hypothesis for the GCC2020 study is that combining ibrutinib (BTK-inhibitor) with indoximod (IDO-inhibitor) during chemotherapy will synergistically enhance anti-tumor immune responses, leading to improvement in clinical response with manageable overlapping toxicity. The GCC2020 trial is a prospective open-label phase 1 trial to determine the best safe dose of the BTK-inhibitor ibrutinib to use in combination with previously studied chemo-immunotherapy regimens comprised of the investigational IDO-inhibitor indoximod plus oral palliative chemotherapy for participants, age 6 to 25 years, with relapsed or refractory primary brain cancer. Those previously treated with indoximod-based therapy may be eligible, including prior treatment via the phase 2 indoximod study (GCC1949, NCT04049669), the now closed phase 1 study (NLG2105, NCT02502708), or any expanded access (compassionate use) protocols. Ibrutinib will be combined with either indoximod plus oral cyclophosphamide and etoposide (Regimen A) or indoximod plus oral temozolomide (Regimen B). No cross-over between these two regimens will be allowed. Dose-escalation cohorts will determine the best safe dose of ibrutinib for each of these regimens. This will be followed by expansion cohorts, using ibrutinib at the best safe dose for each regimen, to allow assessment of preliminary evidence of efficacy.
Primary Outcome
To determine the pediatric recommended phase 2 dose (RP2D) of ibrutinib, when combined with indoximod-based chemo-immunotherapy (Regimen A)
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Etoposide
- DRUG Ibrutinib
- DRUG Indoximod
Study Locations (1)
Georgia
- Augusta University, Georgia Cancer Center - Augusta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 37 participants |
| Start Date | 2022-02-08 |
| Est. Completion | 2028-09-30 |
| Phase | Phase 1 |
What NCT05106296 shows while recruiting
NCT05106296 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 37 participants, a relatively small participant target, below the 109-participant average among 199 other Glioblastoma trials with a reported enrollment target (66% lower).
The record links to 4 conditions, with Glioblastoma appearing as the primary indexed condition, and to 4 interventions - of which Cyclophosphamide is the first listed.
NCT05106296 reports a single indexed study location in Georgia.
Frequently Asked Questions
What is clinical trial NCT05106296 about?
NCT05106296 is a clinical study titled "Chemo-immunotherapy Using Ibrutinib Plus Indoximod for Patients With Pediatric Brain Cancer". Recent lab-based discoveries suggest that IDO (indoleamine 2,3-dioxygenase) and BTK (Bruton's tyrosine Kinase) form a closely linked metabolic checkpoint in tumor-associated antigen-presenting cells. The central clinical hypothesis for the GCC2020 study is that combining ibrutinib (BTK-inhibitor) wi...
What is the current status of trial NCT05106296?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 37 participants. The study started on 2022-02-08. Estimated completion is 2028-09-30.
What conditions does trial NCT05106296 study?
This clinical trial studies the following conditions: Glioblastoma, Medulloblastoma, Ependymoma, Primary Brain Tumor.
What interventions are being tested in trial NCT05106296?
The interventions under investigation include: Cyclophosphamide (DRUG), Etoposide (DRUG), Ibrutinib (DRUG), Indoximod (DRUG).
Who is sponsoring clinical trial NCT05106296?
This trial is sponsored by Theodore S. Johnson, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05106296 being conducted?
This trial has 1 study location across Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT05106296's enrollment target sits among peer trials
37 112th of 199 higher than 86 of 199 other Glioblastoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Glioblastoma 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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