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|NCT02502708 : Study of the IDO Pathway Inhibitor, Indoximod, and Temozolomide for Pediatric Patients With Progressive Primary Malignant Brain Tumors|
|Ages||Min: 3 Years Max: 21 Years|
- Age: 3-21 years.
- Group 1 or Group 3: histologically proven initial diagnosis of primary malignant brain
tumor, with no known curative treatment options.
- Group 2: histologically proven initial diagnosis of high-grade glioma (WHO grade III
and IV), ependymoma, medulloblastoma, or other primary central nervous system tumor.
- Group 3b: Patients with a radiographic diagnosis or histologically proven diagnosis of
diffuse intrinsic pontine glioma (DIPG).
- MRI confirmation of tumor progression or regrowth.
- Patients must be able to swallow whole capsules.
- Patients with metastatic disease are eligible for enrollment.
- Lansky or Karnofsky performance status score must be > 50%.
- Seizure disorders must be well controlled on antiepileptic medication.
- DIPG patients enrolled to Group 3b must not have been previously treated with
radiation or any medical therapy.
- Patients previously treated with temozolomide, cyclophosphamide, and/or etoposide are
eligible for enrollment.
- Prior invasive malignancy, other than the primary central nervous system tumor, unless
the patient has been disease free and off therapy for that disease for a minimum of 3
- Patients with baseline QTc interval of more than 470 msec at study entry, and patients
with congenital long QTc syndrome.
- Active autoimmune disease
|Links||Permanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT02502708
| Link to official Clinicaltrials.gov listing