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Alkylating Agent

Indoximod + Chemotherapy/Radiation for Pediatric Brain Cancer

Phase 2

Recruiting

Led By Theodore S Johnson, MD, PhD

Research Sponsored by Theodore S. Johnson

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Lansky or Karnofsky performance status score must be ≥ 50%

Patients must be 14 days from the administration of any investigational agent or prior cytotoxic therapy

Must not have

Patients previously treated with indoximod

Patients who cannot swallow indoximod pills

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether adding indoximod to chemotherapy and/or radiation improves outcomes for pediatric brain cancer patients.

Who is the study for?

This trial is for children and young adults aged 3 to 21 with progressive brain cancers like glioblastoma, medulloblastoma, ependymoma, or newly diagnosed DIPG. They must be able to swallow pills, have a certain level of physical function (Lansky/Karnofsky score ≥50%), controlled seizures if present, and not have had recent treatments or other specific conditions.

What is being tested?

The trial tests whether adding indoximod immunotherapy to chemotherapy and radiation can improve outcomes in pediatric brain tumors by inhibiting the IDO pathway. It's an open-label phase 2 study comparing standard therapy alone versus the combination including indoximod.

What are the potential side effects?

Potential side effects may include immune-related reactions due to indoximod's effect on the body's immune system. Chemotherapy drugs like Temozolomide could cause nausea, fatigue, hair loss; Cyclophosphamide might lead to bladder irritation; Radiation may result in skin changes or fatigue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can do most activities but need help with some.

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It has been at least 14 days since I last received experimental treatment or chemotherapy.

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My initial diagnosis was glioblastoma, medulloblastoma, or ependymoma and it is getting worse.

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My liver tests are within the required range.

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My blood tests show enough white cells, platelets, and hemoglobin.

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My kidney function, based on creatinine levels, is within the normal range.

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My cancer has spread to other parts of my body.

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I can swallow pills.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been treated with indoximod before.

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I cannot swallow pills.

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I have DIPG and have received previous treatments.

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I do not have an active infection needing treatment, including HIV or toxoplasmosis.

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My brain tumor is in the middle but not affecting the brain stem much.

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I am receiving treatment for an active autoimmune disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

12-month Overall Survival (OS)

8-month iRANO-PFS (Progression-Free Survival, defined by immune-adapted iRANO criteria)

Secondary study objectives

Median Overall Survival (OS)

Median Time to Regimen Failure (TTRF)

Median iRANO-PFS (Progression-Free Survival, defined by immune-adapted iRANO criteria)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

5Treatment groups

Experimental Treatment

Group I: Salvage Regimen 2Experimental Treatment3 Interventions

For patients who wish to continue access to indoximod after progression on the Core Regimen; Cross-over to indoximod with oral lomustine and temozolomide).

Group II: Salvage Regimen 1Experimental Treatment3 Interventions

For patients who wish to continue access to indoximod after progression on the Core Regimen; Cross-over to indoximod with oral metronomic cyclophosphamide and etoposide).

Group III: Core Regimen, sub-cohort CExperimental Treatment3 Interventions

For patients who are eligible for full-dose radiation; (All newly diagnosed DIPG patients and some relapsed ependymoma patients); Start with indoximod plus up-front radiation, using a palliative full-dose radiation plan to all known sites of disease (\>50 Gy to brain, \>45 Gy to spine); Followed by Core Regimen chemo-immunotherapy (indoximod with oral temozolomide).

Group IV: Core Regimen, sub-cohort BExperimental Treatment3 Interventions

For patients who are eligible for partial re-irradiation; Start with indoximod plus up-front re-irradiation, using a palliative low-dose or partial-field radiation plan (low-dose radiation or not all disease sites included); Followed by Core Regimen chemo-immunotherapy (indoximod with oral temozolomide).

Group V: Core Regimen, sub-cohort AExperimental Treatment2 Interventions

For patients not eligible for re-irradiation; Start with Core Regimen chemo-immunotherapy (indoximod with oral temozolomide).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Temozolomide

2010

Completed Phase 3

~1880

Cyclophosphamide

2010