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NCT04049669 · ClinicalTrials.gov registry record · Phase 2
Pediatric Trial of Indoximod With Chemotherapy and Radiation for Relapsed Brain Tumors or Newly Diagnosed DIPG
A Phase 2 study of Glioblastoma and Medulloblastoma, sponsored by Theodore S. Johnson.
- Active
- Registry status
- Phase 2
- Development phase
- 130
- Enrollment target
- 5
- Study locations
NCT04049669: Active Phase 2 study of Glioblastoma and Medulloblastoma, sponsored by Theodore S. Johnson.
NCT04049669 is a Phase 2 study of Glioblastoma and Medulloblastoma that is active but no longer recruiting, run by Theodore S. Johnson. The registered enrollment target is 130 participants, above the 108-participant average among 199 other Glioblastoma trials with a reported enrollment target (20% higher). The trial reports 5 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04049669, a Phase 2 study of Glioblastoma and Medulloblastoma, is active but no longer recruiting, sponsored by Theodore S. Johnson.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 130 participants
- Enrollment target
- 5
- Study locations
Study 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.
Primary Outcome
For patients with relapsed glioblastoma, medulloblastoma, or ependymoma.
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Temozolomide
- DRUG Indoximod
- RADIATION Partial Radiation
- RADIATION Full-dose Radiation
Study Locations (5)
Georgia
- Augusta University, Georgia Cancer Center - Augusta
- Emory University, Children's Heathcare of Atlanta - Druid Hills
Massachusetts
- Dana-Farber Cancer Institute - Boston
Ohio
- Cincinnati Children's Hospital Medical Center - Cincinnati
Texas
- MD Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 130 participants |
| Start Date | 2019-10-02 |
| Est. Completion | 2027-10-02 |
| Phase | Phase 2 |
What the registry record for NCT04049669 still lists
NCT04049669 is an interventional study that assigns participants to a tested intervention. The registered 130 participants enrollment target is mid-sized for trials with a published cap, above the 108-participant average among 199 other Glioblastoma trials with a reported enrollment target (20% higher).
The record links to 4 conditions, with Glioblastoma appearing as the primary indexed condition, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT04049669 lists 5 locations in 4 states (Georgia, Massachusetts, Ohio).
Frequently Asked Questions
What is clinical trial NCT04049669 about?
NCT04049669 is a clinical study titled "Pediatric Trial of Indoximod With Chemotherapy and Radiation for Relapsed Brain Tumors or Newly Diagnosed DIPG". 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 ...
What is the current status of trial NCT04049669?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 130 participants. The study started on 2019-10-02. Estimated completion is 2027-10-02.
What conditions does trial NCT04049669 study?
This clinical trial studies the following conditions: Glioblastoma, Medulloblastoma, Diffuse Intrinsic Pontine Glioma, Ependymoma.
What interventions are being tested in trial NCT04049669?
The interventions under investigation include: Cyclophosphamide (DRUG), Temozolomide (DRUG), Indoximod (DRUG), Partial Radiation (RADIATION), Full-dose Radiation (RADIATION).
Who is sponsoring clinical trial NCT04049669?
This trial is sponsored by Theodore S. Johnson, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04049669 being conducted?
This trial has 5 study locations across Georgia, Massachusetts, Ohio, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT04049669's enrollment target sits among peer trials
130 37th of 199 higher than 163 of 199 other Glioblastoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Glioblastoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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