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

PHASE2RecruitingINTERVENTIONAL
Enrollment

140

Participants

Timeline

Start Date

October 2, 2019

Primary Completion Date

October 2, 2025

Study Completion Date

October 2, 2027

Conditions
GlioblastomaMedulloblastomaEpendymomaDiffuse Intrinsic Pontine Glioma
Interventions
DRUG

Indoximod

Indoximod will be taken by mouth twice daily during radiation and throughout each chemo-immunotherapy treatment cycle.

RADIATION

Partial Radiation

Palliative low-dose or partial-field radiation plan (low-dose radiation or not all disease sites included).

RADIATION

Full-dose Radiation

Palliative full-dose radiation plan to all known sites of disease (\>50 Gy to brain, \>45 Gy to spine).

DRUG

Temozolomide

Temozolomide will be taken by mouth once daily, on days 1-5 of each chemo-immunotherapy treatment cycle.

DRUG

Cyclophosphamide

Cyclophosphamide will be taken by mouth once daily, on days 1-21 of each chemo-immunotherapy treatment cycle.

DRUG

Etoposide

Etoposide will be taken by mouth once daily, on days 1-21 of each chemo-immunotherapy treatment cycle.

DRUG

Lomustine

Lomustine will be taken by mouth once daily, on day 1 of each chemo-immunotherapy treatment cycle.

Trial Locations (5)

30322

ACTIVE_NOT_RECRUITING

Emory University, Children's Heathcare of Atlanta, Druid Hills

30912

RECRUITING

Augusta University, Georgia Cancer Center, Augusta

45229

ACTIVE_NOT_RECRUITING

Cincinnati Children's Hospital Medical Center, Cincinnati

77030

RECRUITING

MD Anderson Cancer Center, Houston

02215

ACTIVE_NOT_RECRUITING

Dana-Farber Cancer Institute, Boston

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

collaborator

Augusta University

OTHER

collaborator

Emory University

OTHER

lead

Theodore S. Johnson

OTHER