Status:
ACTIVE_NOT_RECRUITING
Pediatric Trial of Indoximod With Chemotherapy and Radiation for Relapsed Brain Tumors or Newly Diagnosed DIPG
Lead Sponsor:
Theodore S. Johnson
Collaborating Sponsors:
National Cancer Institute (NCI)
Augusta University
Conditions:
Glioblastoma
Medulloblastoma
Eligibility:
All Genders
3-21 years
Phase:
PHASE2
Brief Summary
Indoximod was developed to inhibit the IDO (indoleamine 2,3-dioxygenase) enzymatic pathway, which is important in the natural regulation of immune responses. This potent immune suppressive mechanism h...
Detailed Description
Disease-specific Cohorts : Cohort 1A, 1B (closed to enrollment): relapsed or refractory glioblastoma Cohort 2A, 2B: relapsed or refractory medulloblastoma Cohort 3A, 3B, 3C: relapsed or refractory ...
Eligibility Criteria
Inclusion
- Diagnosis:
- Progressive disease with histologically proven initial diagnosis of glioblastoma, medulloblastoma, or ependymoma; With confirmation of progression by either MRI or CSF analysis; Measureable disease is not required for study entry; Patients with progressive disease must have been previously treated with therapeutic radiation as part of treatment for the initial brain cancer diagnosis or for a prior relapse.
- Newly diagnosed DIPG (diffuse intrinsic pontine glioma) with no prior therapy (including no prior radiation); Biopsy is not required for DIPG.
- Central review of tissue diagnosis is required, except non-biopsied DIPG; Archival tumor tissue must be located and available prior to study entry.
- Patients with metastatic disease are eligible.
- Lansky or Karnofsky performance status score must be ≥ 50%.
- Adequate renal function: creatinine ≤ 1.5-times upper limit of age-adjusted normal.
- Adequate liver function:
- ALT ≤ 5-times upper limit of normal.
- Total bilirubin ≤ 1.5-times upper limit of normal.
- Adequate Bone marrow function:
- Absolute neutrophil count (ANC) ≥ 750/mcL.
- Platelets ≥ 75,000/mcL (transfusion independent).
- Hemoglobin ≥ 8 g/dL (transfusion independent).
- Central nervous system: seizure disorders must be well controlled on antiepileptic medication.
- Prior therapy
- DIPG patients must not have been treated with any prior radiation or medical therapy.
- Patients previously treated with indoximod are excluded.
- Patients previously treated with any other immunotherapy agent, including other IDO-targeted drugs, are eligible for enrollment.
- Patients previously treated with chemotherapy drugs included in this protocol are eligible for enrollment.
- Patients must be 14 days from the administration of any investigational agent or prior cytotoxic therapy with the following exceptions:
- Temozolomide dosed at or above 150 mg/m2 (allowed, but must be at least 21 days from the last dose of temozolomide).
- Must be 28 days from administration of antibody-based therapies (e.g., bevacizumab), tumor-directed vaccines, or cellular immune therapies (e.g., T cells, NK cells, etc).
- Must be 56 days from administration of tumor-directed therapies using infectious agents (e.g., viruses, bacteria, etc).
- Pregnant women are excluded from this study, where pregnancy is confirmed by a positive urine or serum hCG laboratory test.
- Patients must be able to swallow pills.
- .
Exclusion
- Patients who cannot swallow indoximod pills are excluded.
- Patients previously treated with indoximod are excluded.
- Patients with DIPG who have been treated with any prior radiation or medical therapy are excluded.
- Midline glioma that does not include significant brain stem involvement is not considered DIPG for enrollment purposes, and is excluded.
- Patients with active systemic infection requiring treatment, including any HIV infection or toxoplasmosis, are excluded.
- Patients with active autoimmune disease that requires systemic therapy are excluded.
- Pregnant women are excluded
Key Trial Info
Start Date :
October 2 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 2 2027
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT04049669
Start Date
October 2 2019
End Date
October 2 2027
Last Update
January 8 2026
Active Locations (5)
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1
Augusta University, Georgia Cancer Center
Augusta, Georgia, United States, 30912
2
Emory University, Children's Heathcare of Atlanta
Druid Hills, Georgia, United States, 30322
3
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
4
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229