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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

12-month Overall Survival (OS)

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

Secondary outcome measures

Median Overall Survival (OS)

Median Time to Regimen Failure (TTRF)

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

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

~1930

Cyclophosphamide

1995

Completed Phase 3

~3770

Indoximod

2014

Completed Phase 2

~750

Lomustine

2008

Completed Phase 3

~1540

Etoposide

2010

Completed Phase 3

~2440

0 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH

13,662 Previous Clinical Trials

40,925,933 Total Patients Enrolled

89 Trials studying Medulloblastoma

10,201 Patients Enrolled for Medulloblastoma

Emory UniversityOTHER

1,638 Previous Clinical Trials

2,560,392 Total Patients Enrolled

3 Trials studying Medulloblastoma

58 Patients Enrolled for Medulloblastoma

Theodore S. JohnsonLead Sponsor

1 Previous Clinical Trials

37 Total Patients Enrolled

1 Trials studying Medulloblastoma

37 Patients Enrolled for Medulloblastoma

Media Library

Cyclophosphamide (Alkylating Agent) Clinical Trial Eligibility Overview. Trial Name: NCT04049669 — Phase 2

Medulloblastoma Research Study Groups: Core Regimen, sub-cohort C, Salvage Regimen 1, Salvage Regimen 2, Core Regimen, sub-cohort B, Core Regimen, sub-cohort A

Medulloblastoma Clinical Trial 2023: Cyclophosphamide Highlights & Side Effects. Trial Name: NCT04049669 — Phase 2

Cyclophosphamide (Alkylating Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04049669 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the most common diagnoses that doctors use Partial Radiation to attempt to improve?

"While most often used to combat lung cancer, partial radiation can also help those suffering from small cell lung cancer (sclc), disease progression, and multiple sclerosis."

Answered by AI

How many research facilities are investigating this topic?

"There are 4 primary sites for this trial, with locations in Cincinnati, Druid Hills and Augusta. There may be other smaller clinics near you as well, which would reduce the amount of travel needed if you enroll."

Answered by AI

Would this experiment's results be skewed if the patients were significantly older?

"This trial is for children and adolescents aged 3 to 21. Out of 573 clinical trials that involve patients under 18, this one is specific to individuals in this age group. For perspective, there are 1,750 trials underway involving patients over the age of 65."

Answered by AI

Could I possibly take part in this experiment?

"The eligibility requirements for this study include being between the ages of 3-21 and having been diagnosed with medulloblastoma. A total of 140 individuals are needed for the trial."

Answered by AI

Is there a high risk of negative side effects from Partial Radiation therapy?

"As this is a Phase 2 trial, there is evidence suggesting that Partial Radiation is safe but not necessarily effective. Our team at Power rated it as a 2."

Answered by AI

Are there other ongoing or previous research projects that have used Partial Radiation?

"There are a total of 1247 ongoing clinical trials related to Partial Radiation. Of these, 236 have reached Phase 3. The majority of research operations for this treatment are based in Philadelphia; however, there are 40594 locations running studies on Partial Radiation."

Answered by AI

Is this research project still recruiting participants?

"Yes, this is an active clinical trial that has been recruiting since October 2nd, 2019. The latest update to the study was on September 18th, 2020. So far, 140 people have signed up at 4 locations."

Answered by AI

Recent research and studies

ImmunityJournal

Inhibition of the Btk-ido-mtor Axis Promotes Differentiation of Monocyte-lineage Dendritic Cells and Enhances Anti-tumor T Cell Immunity

Sharma, Madhav D., Rafal Pacholczyk, Huidong Shi, Zuzana J. Berrong, Yousef Zakharia, Austin Greco, Chang-Sheng S. Chang, et al.. 2021. “Inhibition of the Btk-ido-mtor Axis Promotes Differentiation of Monocyte-lineage Dendritic Cells and Enhances Anti-tumor T Cell Immunity”. Immunity. Elsevier BV. doi:10.1016/j.immuni.2021.09.005.

clinicaltrials.govStudy

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

Theodore S. Johnson 2019. "Pediatric Trial of Indoximod With Chemotherapy and Radiation for Relapsed Brain Tumors or Newly Diagnosed DIPG". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04049669.

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