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Pediatric Trial of Indoximod With Chemotherapy and Radiation for Relapsed Brain Tumors or Newly Diagnosed DIPG


Active: Yes
Cancer Type: Brain & Spinal Cord Tumor NCT ID: NCT04049669
Trial Phases: Phase II Protocol IDs: GCC1949 (primary)
NCI-2019-08285
R01CA229646
Eligibility: 3 - 21 Years, Male and Female Study Type: Treatment
Study Sponsor: Theodore S. Johnson
NCI Full Details: http://clinicaltrials.gov/show/NCT04049669

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 has been implicated in regulating immune responses in
settings as diverse as infection, tissue/organ transplant, autoimmunity, and cancer. By
inhibiting the IDO pathway, we hypothesize that indoximod will improve antitumor immune
responses and thereby slow the growth of tumors.

The central clinical hypothesis for the GCC1949 study is that inhibiting the pivotal IDO
pathway by adding indoximod immunotherapy during chemotherapy and/or radiation is a
potent approach for breaking immune tolerance to pediatric tumors that will improve
outcomes, relative to standard therapy alone.

This is an NCI-funded (R01 CA229646, MPI: Johnson and Munn) open-label phase 2 trial
using indoximod-based combination chemo-radio-immunotherapy for treatment of patients age
3 to 21 years who have progressive brain cancer (glioblastoma, medulloblastoma, or
ependymoma), or newly-diagnosed diffuse intrinsic pontine glioma (DIPG). Statistical
analysis will stratify patients based on whether their treatment plan includes up-front
radiation (or proton) therapy in combination with indoximod. Central review of tissue
diagnosis from prior surgery is required, except non-biopsied DIPG. This study will use
the "immune-adapted Response Assessment for Neuro-Oncology" (iRANO) criteria for
measurement of outcomes. Planned enrollment is up to 140 patients.

Objectives

Disease-specific Cohorts :

Cohort 1A, 1B: progressive glioblastoma (relapsed or refractory)

Cohort 2A, 2B: progressive medulloblastoma (relapsed or refractory)

Cohort 3A, 3B, 3C: progressive ependymoma (relapsed or refractory)

Cohort 4C: newly-diagnosed DIPG (must have no prior radiation or other therapy)

.

Radiation (or proton) plan sub-cohorts:

Sub-cohort A: for patients not eligible for re-irradiation

Sub-cohort B: for patients who are eligible for partial re-irradiation

Sub-cohort C: for patients who are eligible for full-dose radiation (All newly diagnosed
DIPG patients and some relapsed ependymoma patients)

Treatment Sites in Georgia

Aflac Cancer and Blood Disorders Center of Children’s at Egleston
1405 Clifton Road NE
3rd Floor
Atlanta, GA 30322
404-785-0853
www.choa.org



Augusta University Medical Center
1120 15th Street
Augusta, GA 30912
706-721-4430
www.augustahealth.org

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.