At a glance
ClinicalIndex Comparison Record- ✓Histologically proven diagnosis of ependymoma, medulloblastoma, glioblastoma, or other primary CNS cancer
- ✓Progressive or refractory disease with no curative conventional therapy options
- ✓MRI confirmation with and without gadolinium contrast of current active disease
- ✓Able to swallow pills
- ✕Unable to swallow pills
- ✕Known hypersensitivity to any drugs in treatment plan
- ✕Active autoimmune disease requiring systemic therapy
- ✕Pregnant or breastfeeding
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 1 clinical trial evaluating Indoximod, Ibrutinib, and 3 other interventions for Ependymoma and 3 related conditions. Currently recruiting, targeting 37 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Indoximod will be taken by mouth twice daily, throughout each treatment cycle.
For Regimen A, Ibrutinib will be taken by mouth once daily, on days 1-21 of each treatment cycle.
Cyclophosphamide will be taken by mouth once daily, on days 1-21 of each treatment cycle.
Etoposide will be taken by mouth once daily, on days 1-21 of each treatment cycle.
For Regimen B, Ibrutinib will be taken by mouth once daily, on days 1-14 of each treatment cycle.
Temozolomide will be taken by mouth once daily, on days 1-5 of each treatment cycle.