Chemo-immunotherapy Using Ibrutinib Plus Indoximod for Patients With Pediatric Brain Cancer

Part of paid clinical trials in Augusta, Georgia.

Sponsor
Theodore S. Johnson
Study ID
NCT05106296
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
3 Years - 25 Years
Healthy Volunteers
Not accepted

Interventions

  • Indoximod — DRUG
    Indoximod will be taken by mouth twice daily, throughout each treatment cycle.
  • Ibrutinib — DRUG
    For Regimen A, Ibrutinib will be taken by mouth once daily, on days 1-21 of each treatment cycle.
  • Cyclophosphamide — DRUG
    Cyclophosphamide will be taken by mouth once daily, on days 1-21 of each treatment cycle.
  • Etoposide — DRUG
    Etoposide will be taken by mouth once daily, on days 1-21 of each treatment cycle.
  • Ibrutinib — DRUG
    For Regimen B, Ibrutinib will be taken by mouth once daily, on days 1-14 of each treatment cycle.
  • Temozolomide — DRUG
    Temozolomide will be taken by mouth once daily, on days 1-5 of each treatment cycle.

Study Details

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.

Key Dates

Start date
Feb 8, 2022
Status verified
Jan 2026
Primary completion
Mar 30, 2028
Completion
Sep 30, 2028

Study Design

Enrollment
37 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Regimen A
    Patients will be treated with ibrutinib plus indoximod, cyclophosphamide, and etoposide. Cycles are a minimum of 28 days.
  • Experimental: Regimen B
    Patients will be treated with ibrutinib plus indoximod and temozolomide. Cycles are a minimum of 28 days.

Primary Outcome Measure

Incidence of regimen-limiting toxicity (RLT) for Regimen A [ Time Frame: First 90 days of treatment ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Augusta University, Georgia Cancer CenterAugustaGeorgia30912
Theodore S Johnson, MD, PhD
[email protected]
706-721-4962
Robin Dobbins, RN
[email protected]
706-721-2154
Theodore S Johnson, MD, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Augusta, GA

By condition
Brain cancer
By specialty
OncologyNeuro-oncology
By research site
Augusta University, Georgia Cancer Center· Augusta, GA

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