NCT04049669
Pediatric Trial of Indoximod With Chemotherapy and Radiation for Relapsed Brain Tumors or Newly Diagnosed DIPG
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Record History
All 22 versions: 22 with changes below. See every version on ClinicalTrials.gov ↗
Minor Primary completion date changed from estimate of Aug 2, 2026 to Sep 21, 2026 Show 4 more changesShow less
- Study completion pushed from Oct 2, 2027 to Dec 11, 2027
- Eligibility criteria expanded, about 16 words
- Site details revised at 2 of 5 sites
- Publications: details revised at 2 of 2 entries
- Notable Primary completion date: Oct 2, 2025 to Aug 2, 2026
- Trial status: Recruiting to Active, Not Recruiting
- Enrollment target: estimated 140 to confirmed 130
- Site details revised at 5 of 5 sites
- Minor Site contacts updated at 1 of 5 sitesv20
- Minor Site details revised at 1 of 5 sitesv19
- Minor Study sites: 4 to 5v18
Show 16 earlier versionsHide 16 earlier versions
- Minor Study sites revised (4)
- Study description expanded, about 3 words
- Minor Site contacts updated at 1 of 4 sitesv16
- Minor Site contacts updated at 1 of 4 sitesv15
- Study Status, Referencesv14
- Minor Site contacts updated at 1 of 4 sitesv13
- Minor Site contacts updated at 1 of 4 sitesv12
- Minor Site details revised at 1 of 4 sitesv11
- Minor Site contacts updated at 1 of 4 sitesv10
- Minor Study sites: 3 to 4v9
- Minor Site details revised at 1 of 3 sitesv8
- Notable Primary completion date: Oct 2, 2024 to Oct 2, 2025
- Study sites: 2 to 3
- Study completion date: Oct 2, 2026 to Oct 2, 2027
- Minor Interventions: Cyclophosphamide (Drug), Etoposide (Drug), Full-dose Radiation (Radiation), Indoximod (Drug), Indoximod (Drug), Lomustine (Drug), Partial… to Cyclophosphamide (Drug), Etoposide (Drug), Full-dose Radiation (Radiation), Indoximod (Drug), Lomustine (Drug), Partial Radiation…
- Secondary endpoints revised (3)
- Minor Site contacts updated at 1 of 2 sitesv5
- Minor Site details revised at 2 of 2 sitesv4
- Minor Site details revised at 2 of 2 sites
- Collaborators: 2 to 3
Notable Trial status: Not Yet Recruiting to Recruitingv2 Show 5 more changesShow less
- Primary completion date: Sep 2024 to Oct 2, 2024
- Study completion date: Sep 2026 to Oct 2, 2026
- Start date changed from estimate of Sep 2019 to Oct 2, 2019
- Site details revised at 2 of 2 sites
- Collaborators: 1 to 2
- Study First Submitted
- Notable: the plan changed
- Minor: routine updates
Endpoints
Primary
Secondary (3)
Arms and interventions
For patients not eligible for re-irradiation; Start with Core Regimen chemo-immunotherapy (indoximod with oral temozolomide).
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).
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).
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).
For patients who wish to continue access to indoximod after progression on the Core Regimen; Cross-over to indoximod with oral lomustine and temozolomide).
Drugs: Indoximod, Temozolomide, Cyclophosphamide, Etoposide, Lomustine
Radiation: Partial Radiation, Full-dose Radiation
Sites
5 sites in 1 country