Clinical Trial Details
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NCT02502708 : Study of the IDO Pathway Inhibitor, Indoximod, and Temozolomide for Pediatric Patients With Progressive Primary Malignant Brain Tumors
PhasePhase 1
AgesMin: 3 Years Max: 21 Years
Eligibility Criteria

- 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.

Exclusion Criteria

- 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
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