Pediatric Study of Indoximod with Chemotherapy and Radiation for Relapsed Brain Tumors or Newly Diagnosed DIPG

Sponsor: Theodore S. Johnson

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04049669

Provider View

This clinical trial is testing a new treatment that combines the drug Indoximod with chemotherapy and radiation to see if it can help children and young adults with certain brain tumors, including relapsed brain tumors and newly diagnosed DIPG, by boosting the immune system's response to cancer.

Patient Parameters

Program Overview

The study aims to find out if adding Indoximod, a drug that helps the immune system fight cancer, to standard chemotherapy and radiation can improve treatment outcomes for children and young adults aged 3 to 21 with certain brain tumors. These include relapsed glioblastoma, medulloblastoma, ependymoma, and newly diagnosed diffuse intrinsic pontine glioma (DIPG). The trial will involve up to 140 participants and will use specific criteria to measure how well the treatment works.

Description

The study is divided into different groups based on the type of brain tumor and treatment plan:

  • Cohort 1A, 1B (closed): For relapsed or hard-to-treat glioblastoma.
  • Cohort 2A, 2B: For relapsed or hard-to-treat medulloblastoma.
  • Cohort 3A, 3B, 3C: For relapsed or hard-to-treat ependymoma.
  • Cohort 4C (closed): For newly diagnosed DIPG with no prior treatment.

Radiation plan sub-groups:

  • Sub-cohort A: For patients not eligible for more radiation.
  • Sub-cohort B: For patients eligible for partial radiation.
  • Sub-cohort C: For patients eligible for full-dose radiation (includes all newly diagnosed DIPG patients and some relapsed ependymoma patients).

Eligibility Criteria

Inclusion Criteria

  • Have a progressive brain tumor like glioblastoma, medulloblastoma, or ependymoma, confirmed by MRI or spinal fluid tests. Previous radiation treatment is required.
  • Have newly diagnosed DIPG with no prior treatment. A biopsy is not needed for DIPG.
  • Provide a tumor sample from a previous surgery, except for non-biopsied DIPG.
  • Have metastatic disease (cancer that has spread) is allowed.
  • Have a performance status score of 50% or higher, indicating the ability to carry out daily activities.
  • Have adequate kidney and liver function based on specific blood tests.
  • Have adequate bone marrow function, with certain levels of blood cells.
  • Have well-controlled seizure disorders if present.
  • Have not been treated with Indoximod before.
  • Have not received any prior radiation or medical therapy for DIPG.
  • Have not been treated with any investigational drugs or certain therapies within specified time frames before the study.
  • Be able to swallow pills.
  • Not be pregnant, confirmed by a pregnancy test.

Exclusion Criteria

  • Cannot swallow Indoximod pills.
  • Have been treated with Indoximod before.
  • Have DIPG and have received prior radiation or medical therapy.
  • Have a midline glioma without significant brain stem involvement.
  • Have an active systemic infection requiring treatment, including HIV or toxoplasmosis.
  • Have an active autoimmune disease requiring systemic therapy.
  • Are pregnant.

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