GlioblastomaPhase 2NCT04049669
Pediatric Trial of Indoximod With Chemotherapy and Radiation for Relapsed Brain Tumors or Newly Diagnosed DIPG
A Phase 2 study testing Indoximod, Partial Radiation and Full-dose Radiation in people with Glioblastoma and Medulloblastoma, run by Theodore S. Johnson at 5 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 3 to 21 years
- Conditions the study is for
- Glioblastoma, Medulloblastoma, Ependymoma
- What is being tested?
- Indoximod, Partial Radiation and Full-dose Radiation
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 5 sitesUnited States
- Study dates
- 2 Oct 2019to 11 Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Diagnosis:
- Progressive disease with histologically proven initial diagnosis of glioblastoma, medulloblastoma, or ependymoma; With confirmation of progression by either MRI or CSF analysis; Measureable disease is not required for study entry; Patients with progressive disease must have been previously treated with therapeutic radiation as part of treatment for the initial brain cancer diagnosis or for a prior relapse.
- Newly diagnosed DIPG (diffuse intrinsic pontine glioma) with no prior therapy (including no prior radiation); Biopsy is not required for DIPG.
- Central review of tissue diagnosis is required, except non-biopsied DIPG; Archival tumor tissue must be located and available prior to study entry.
- Patients with metastatic disease are eligible.
- Lansky or Karnofsky performance status score must be ≥ 50%.
Show all 27Show fewer
- Adequate renal function: creatinine ≤ 1.5-times upper limit of age-adjusted normal.
- Adequate liver function:
- ALT ≤ 5-times upper limit of normal.
- Total bilirubin ≤ 1.5-times upper limit of normal.
- Adequate Bone marrow function:
- Absolute neutrophil count (ANC) ≥ 750/mcL.
- Platelets ≥ 75,000/mcL (transfusion independent).
- Hemoglobin ≥ 8 g/dL (transfusion independent).
- Central nervous system: seizure disorders must be well controlled on antiepileptic medication.
- Prior therapy
- DIPG patients must not have been treated with any prior radiation or medical therapy.
- Patients previously treated with indoximod are excluded.
- Patients previously treated with any other immunotherapy agent, including other IDO-targeted drugs, are eligible for enrollment.
- Patients previously treated with chemotherapy drugs included in this protocol are eligible for enrollment.
- Patients must be 14 days from the administration of any investigational agent or prior cytotoxic therapy with the following exceptions:
- Temozolomide dosed at or above 150 mg/m2 (allowed, but must be at least 21 days from the last dose of temozolomide).
- Must be 28 days from administration of antibody-based therapies (e.g., bevacizumab), tumor-directed vaccines, or cellular immune therapies (e.g., T cells, NK cells, etc).
- Must be 56 days from administration of tumor-directed therapies using infectious agents (e.g., viruses, bacteria, etc).
- Pregnant women are excluded from this study, where pregnancy is confirmed by a positive urine or serum hCG laboratory test.
- Patients must be able to swallow pills.
- .
Who cannot join
- Patients who cannot swallow indoximod pills are excluded.
- Patients previously treated with indoximod are excluded.
- Patients with DIPG who have been treated with any prior radiation or medical therapy are excluded.
- Midline glioma that does not include significant brain stem involvement is not considered DIPG for enrollment purposes, and is excluded.
- Patients with active systemic infection requiring treatment, including any HIV infection or toxoplasmosis, are excluded.
- Patients with active autoimmune disease that requires systemic therapy are excluded.
- Pregnant women are excluded
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Augusta University, Georgia Cancer Center
Augusta, Georgia, 30912
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Emory University, Children's Heathcare of Atlanta
Druid Hills, Georgia, 30322
MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: Phase 2 Trial of Indoximod With Chemotherapy and Radiation for Children With Progressive 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 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.
Read the detailed description
Disease-specific Cohorts :
Cohort 1A, 1B (closed to enrollment): relapsed or refractory glioblastoma
Cohort 2A, 2B: relapsed or refractory medulloblastoma
Cohort 3A, 3B, 3C: relapsed or refractory ependymoma
Cohort 4C (closed to enrollment): 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)
- Being tested
- Indoximod, Partial Radiation, Full-dose Radiation, Temozolomide, Cyclophosphamide
- Keywords
- IDO, indoleamine 2,3-dioxygenase, indoximod, pediatric, childhood, brain tumor, glioblastoma, medulloblastoma, ependymoma, diffuse intrinsic pontine glioma, DIPG, radiation, temozolomide, cyclophosphamide, etoposide, lomustine, immunotherapy, immune, central nervous system, CNS
- Medical subject headings
- Glioblastoma, Medulloblastoma, Ependymoma, Diffuse Intrinsic Pontine Glioma, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IndoximodDrug
Indoximod will be taken by mouth twice daily during radiation and throughout each chemo-immunotherapy treatment cycle.
Partial RadiationRadiation
Palliative low-dose or partial-field radiation plan (low-dose radiation or not all disease sites included).
Full-dose RadiationRadiation
Palliative full-dose radiation plan to all known sites of disease (>50 Gy to brain, >45 Gy to spine).
TemozolomideDrug
Temozolomide will be taken by mouth once daily, on days 1-5 of each chemo-immunotherapy treatment cycle.
CyclophosphamideDrug
Cyclophosphamide will be taken by mouth once daily, on days 1-21 of each chemo-immunotherapy treatment cycle.
EtoposideDrug
Etoposide will be taken by mouth once daily, on days 1-21 of each chemo-immunotherapy treatment cycle.
LomustineDrug
Lomustine will be taken by mouth once daily, on day 1 of each chemo-immunotherapy treatment cycle.
| Study group | Role | What they receive |
|---|---|---|
| Core Regimen, sub-cohort A | Experimental | For patients not eligible for re-irradiation; Start with Core Regimen chemo-immunotherapy (indoximod with oral temozolomide). Receives: Drug: Indoximod; Drug: Temozolomide |
| Core Regimen, sub-cohort B | Experimental | 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). Receives: Drug: Indoximod; Radiation: Partial Radiation; Drug: Temozolomide |
| Core Regimen, sub-cohort C | Experimental | 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). Receives: Drug: Indoximod; Radiation: Full-dose Radiation; Drug: Temozolomide |
| Salvage Regimen 1 | Experimental | 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). Receives: Drug: Indoximod; Drug: Cyclophosphamide; Drug: Etoposide |
| Salvage Regimen 2 | Experimental | For patients who wish to continue access to indoximod after progression on the Core Regimen; Cross-over to indoximod with oral lomustine and temozolomide). Receives: Drug: Indoximod; Drug: Temozolomide; Drug: Lomustine |
What is being measured
The primary outcome is the main question the study is designed to answer.
8-month iRANO-PFS (Progression-Free Survival, defined by immune-adapted iRANO criteria)
For patients with relapsed glioblastoma, medulloblastoma, or ependymoma.
Measured: Up to 5 years
12-month Overall Survival (OS)
For patients with newly diagnosed DIPG (diffuse intrinsic pontine glioma).
Measured: Up to 5 years
Secondary outcomes (3)
Median Overall Survival (OS)
For each disease cohort
Measured: Up to 5 years
Median iRANO-PFS (Progression-Free Survival, defined by immune-adapted iRANO criteria)
For each disease cohort
Measured: Up to 5 years
Median Time to Regimen Failure (TTRF)
For each disease cohort
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2019
- Study start2 Oct 2019
- Primary completion21 Sep 2026
- Study completion11 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Theodore S. Johnson
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Augusta University, Emory University
- Responsible party
- Sponsor-investigator, Theodore S. Johnson, Augusta University
- Investigators
- Theodore S Johnson, MD, PhD, Principal investigator, Augusta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04049669
- Sponsor's protocol ID
- GCC1949
- Other IDs
- R01CA229646
- Status last verified
- Oct 2026
- First submitted
- 2 Aug 2019
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Johnson TS, MacDonald TJ, Pacholczyk R, Aguilera D, Al-Basheer A, Bajaj M, Bandopadhayay P, Berrong Z, Bouffet E, Castellino RC, Dorris K, Eaton BR, Esiashvili N, Fangusaro JR, Foreman N, Fridlyand D, Giller C, Heger IM, Huang C, Kadom N, Kennedy EP, Manoharan N, Martin W, McDonough C, Parker RS, Ramaswamy V, Ring E, Rojiani A, Sadek RF, Satpathy S, Schniederjan M, Smith A, Smith C, Thomas BE, Vaizer R, Yeo KK, Bhasin MK, Munn DH. Indoximod-based chemo-immunotherapy for pediatric brain tumors: A first-in-children phase I trial. Neuro Oncol. 2024 Feb 2;26(2):348-361. doi: 10.1093/neuonc/noad174.
PubMed 37715730Sharma MD, Pacholczyk R, Shi H, Berrong ZJ, Zakharia Y, Greco A, Chang CS, Eathiraj S, Kennedy E, Cash T, Bollag RJ, Kolhe R, Sadek R, McGaha TL, Rodriguez P, Mandula J, Blazar BR, Johnson TS, Munn DH. Inhibition of the BTK-IDO-mTOR axis promotes differentiation of monocyte-lineage dendritic cells and enhances anti-tumor T cell immunity. Immunity. 2021 Oct 12;54(10):2354-2371.e8. doi: 10.1016/j.immuni.2021.09.005. Epub 2021 Oct 5.
PubMed 34614413
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Trial of Indoximod With Chemotherapy and Radiation for Children With Progressive Brain Tumors or Newly Diagnosed DIPG
- ClinicalTrials.gov ID
- NCT04049669
- Acronym / sponsor ID
- GCC1949
- Keywords
- IDO, indoleamine 2,3-dioxygenase, indoximod, pediatric, childhood, brain tumor, glioblastoma, medulloblastoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Theodore S. JohnsonUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Augusta University, Emory University
- Study start
- 2 Oct 2019 (actual)
- Primary completion
- 21 Sep 2026 (actual)
- Study completion
- 11 Dec 2027 (estimated)
- First posted
- 8 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Disease-specific Cohorts :
Cohort 1A, 1B (closed to enrollment): relapsed or refractory glioblastoma
Cohort 2A, 2B: relapsed or refractory medulloblastoma
Cohort 3A, 3B, 3C: relapsed or refractory ependymoma
Cohort 4C (closed to enrollment): 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)
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Core Regimen, sub-cohort A | Experimental | Drug: Indoximod, Drug: TemozolomideFor patients not eligible for re-irradiation; Start with Core Regimen chemo-immunotherapy (indoximod with oral temozolomide). |
| Core Regimen, sub-cohort B | Experimental | Drug: Indoximod, Radiation: Partial Radiation, Drug: TemozolomideFor 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). |
| Core Regimen, sub-cohort C | Experimental | Drug: Indoximod, Radiation: Full-dose Radiation, Drug: TemozolomideFor 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). |
| Salvage Regimen 1 | Experimental | Drug: Indoximod, Drug: Cyclophosphamide, Drug: EtoposideFor patients who wish to continue access to indoximod after progression on the Core Regimen; Cross-over to indoximod with oral metronomic cyclophosphamide and etoposide). |
| Salvage Regimen 2 | Experimental | Drug: Indoximod, Drug: Temozolomide, Drug: LomustineFor patients who wish to continue access to indoximod after progression on the Core Regimen; Cross-over to indoximod with oral lomustine and temozolomide). |
Who may qualify
- Ages
- 3 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (27 listed)
- Progressive disease with histologically proven initial diagnosis of glioblastoma, medulloblastoma, or ependymoma; With confirmation of progression by either MRI or CSF analysis; Measureable disease is not required for study entry; Patients with progressive disease must have been previously treated with therapeutic radiation as part of treatment for the initial brain cancer diagnosis or for a prior relapse.
- Newly diagnosed DIPG (diffuse intrinsic pontine glioma) with no prior therapy (including no prior radiation); Biopsy is not required for DIPG.
- Central review of tissue diagnosis is required, except non-biopsied DIPG; Archival tumor tissue must be located and available prior to study entry.
- Patients with metastatic disease are eligible.
- Lansky or Karnofsky performance status score must be ≥ 50%.
Key exclusion criteria (7 listed)
- Patients who cannot swallow indoximod pills are excluded.
- Patients previously treated with indoximod are excluded.
- Patients with DIPG who have been treated with any prior radiation or medical therapy are excluded.
- Midline glioma that does not include significant brain stem involvement is not considered DIPG for enrollment purposes, and is excluded.
- Patients with active systemic infection requiring treatment, including any HIV infection or toxoplasmosis, are excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IndoximodIndoximod will be taken by mouth twice daily during radiation and throughout each chemo-immunotherapy treatment cycle. | Drug | Core Regimen, sub-cohort A, Core Regimen, sub-cohort B, Core Regimen, sub-cohort C, Salvage Regimen 1, Salvage Regimen 2 |
| Partial RadiationPalliative low-dose or partial-field radiation plan (low-dose radiation or not all disease sites included). | Radiation | Core Regimen, sub-cohort B |
| Full-dose RadiationPalliative full-dose radiation plan to all known sites of disease (>50 Gy to brain, >45 Gy to spine). | Radiation | Core Regimen, sub-cohort C |
| TemozolomideTemozolomide will be taken by mouth once daily, on days 1-5 of each chemo-immunotherapy treatment cycle. | Drug | Core Regimen, sub-cohort A, Core Regimen, sub-cohort B, Core Regimen, sub-cohort C, Salvage Regimen 2 |
| CyclophosphamideCyclophosphamide will be taken by mouth once daily, on days 1-21 of each chemo-immunotherapy treatment cycle. | Drug | Salvage Regimen 1 |
| EtoposideEtoposide will be taken by mouth once daily, on days 1-21 of each chemo-immunotherapy treatment cycle. | Drug | Salvage Regimen 1 |
| LomustineLomustine will be taken by mouth once daily, on day 1 of each chemo-immunotherapy treatment cycle. | Drug | Salvage Regimen 2 |
Primary outcome
8-month iRANO-PFS (Progression-Free Survival, defined by immune-adapted iRANO criteria)
Time frame: Up to 5 years
For patients with relapsed glioblastoma, medulloblastoma, or ependymoma.
12-month Overall Survival (OS)
Time frame: Up to 5 years
For patients with newly diagnosed DIPG (diffuse intrinsic pontine glioma).
3 secondary outcomes
Median Overall Survival (OS)
Time frame: Up to 5 years
Median iRANO-PFS (Progression-Free Survival, defined by immune-adapted iRANO criteria)
Time frame: Up to 5 years
Median Time to Regimen Failure (TTRF)
Time frame: Up to 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Background: PubMed 37715730Johnson TS, MacDonald TJ, Pacholczyk R, Aguilera D, Al-Basheer A, Bajaj M, Bandopadhayay P, Berrong Z, Bouffet E, Castellino RC, Dorris K, Eaton BR, Esiashvili N, Fangusaro JR, Foreman N, Fridlyand D, Giller C, Heger IM, Huang C, Kadom N, Kennedy EP, Manoharan N, Martin W, McDonough C, Parker RS, Ramaswamy V, Ring E, Rojiani A, Sadek RF, Satpathy S, Schniederjan M, Smith A, Smith C, Thomas BE, Vaizer R, Yeo KK, Bhasin MK, Munn DH. Indoximod-based chemo-immunotherapy for pediatric brain tumors: A first-in-children phase I trial. Neuro Oncol. 2024 Feb 2;26(2):348-361. doi: 10.1093/neuonc/noad174.
- Background: PubMed 34614413Sharma MD, Pacholczyk R, Shi H, Berrong ZJ, Zakharia Y, Greco A, Chang CS, Eathiraj S, Kennedy E, Cash T, Bollag RJ, Kolhe R, Sadek R, McGaha TL, Rodriguez P, Mandula J, Blazar BR, Johnson TS, Munn DH. Inhibition of the BTK-IDO-mTOR axis promotes differentiation of monocyte-lineage dendritic cells and enhances anti-tumor T cell immunity. Immunity. 2021 Oct 12;54(10):2354-2371.e8. doi: 10.1016/j.immuni.2021.09.005. Epub 2021 Oct 5.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Theodore S Johnson, MD, PhD principal investigator
Augusta University
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Indoximod, Partial Radiation and Full-dose Radiation in people with Glioblastoma and Medulloblastoma, run by Theodore S. Johnson at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 27 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
8-month iRANO-PFS (Progression-Free Survival, defined by immune-adapted iRANO criteria) (time frame: Up to 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04049669, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.