Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
PlainTrials
RecruitingPhase 1interventionalRules rewrite

Phase 1: testing Indoximod for Ependymoma

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.

Official registry: https://clinicaltrials.gov/study/NCT05106296 · Theodore S. Johnson · enrollment listed as 37

What this phase means

Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Indoximod, Ibrutinib, or Cyclophosphamide. The registry lists allocation as randomized. 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.

They plan to enroll about 37 people at Augusta. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

Repurposing Ibrutinib for Chemo-Immunotherapy in a Phase 1b Study of Ibrutinib With Indoximod Plus Metronomic Cyclophosphamide and Etoposide for Pediatric Patients With Brain Cancer

Interventions: Indoximod, Ibrutinib, Cyclophosphamide, Etoposide, Ibrutinib, Temozolomide

Primary outcome (registry wording): Incidence of regimen-limiting toxicity (RLT) for Regimen A

Who it is for (from inclusion criteria)

  • Ages 3 Years to 25 Years
  • Metastatic disease is acceptable
  • Patients must have MRI confirmation (with and without gadolinium contrast) of current active disease
  • Patients must be able to swallow pills
  • Lansky or Karnofsky performance status score must be ≥ 50%
  • Adequate renal function:
  • Creatinine clearance (CLcr) \> 25 mL/min (by calculated methods) AND Creatinine ≤ 1.5-times upper limit of age-adjusted normal for age of patient
  • Adequate liver function:

Public study contact (from the registry)

Theodore S. Johnson, MD, PhD

706-721-4962

thjohnson@augusta.edu

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

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FAQ about this NCT record

Is NCT05106296 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT05106296?

Phase 1. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT05106296?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary