Study of the IDO Pathway Inhibitor, Indoximod, and Temozolomide for Pediatric Patients With Progressive Primary Malignant Brain Tumors
| Status: | Recruiting |
|---|---|
| Conditions: | Brain Cancer, Brain Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 3 - 21 |
| Updated: | 7/4/2018 |
| Start Date: | October 2015 |
| End Date: | December 2019 |
| Contact: | Chris Smith, MS |
| Email: | csmith@linkp.com |
| Phone: | 515-598-5020 |
A Phase I Trial of Indoximod and Temozolomide-Based Therapy for Children With Progressive Primary Brain Tumors
This is a first-in-children phase 1 trial using indoximod, an inhibitor of the immune
"checkpoint" pathway indoleamine 2,3-dioxygenase (IDO), in combination with
temozolomide-based therapy to treat pediatric brain tumors. Using a preclinical glioblastoma
model, it was recently shown that adding IDO-blocking drugs to temozolomide plus radiation
significantly enhanced survival by driving a vigorous, tumordirected inflammatory response.
This data provided the rationale for the companion adult phase 1 trial using indoximod
(IND#120813) plus temozolomide to treat adults with glioblastoma, which is currently open
(NCT02052648). The goal of this pediatric study is to bring IDO-based immunotherapy into the
clinic for children with brain tumors. This study will provide a foundation for future
pediatric trials testing indoximod combined with radiation and temozolomide in the up-front
setting for patients with newly diagnosed central nervous system tumors.
"checkpoint" pathway indoleamine 2,3-dioxygenase (IDO), in combination with
temozolomide-based therapy to treat pediatric brain tumors. Using a preclinical glioblastoma
model, it was recently shown that adding IDO-blocking drugs to temozolomide plus radiation
significantly enhanced survival by driving a vigorous, tumordirected inflammatory response.
This data provided the rationale for the companion adult phase 1 trial using indoximod
(IND#120813) plus temozolomide to treat adults with glioblastoma, which is currently open
(NCT02052648). The goal of this pediatric study is to bring IDO-based immunotherapy into the
clinic for children with brain tumors. This study will provide a foundation for future
pediatric trials testing indoximod combined with radiation and temozolomide in the up-front
setting for patients with newly diagnosed central nervous system tumors.
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
years
- Patients with baseline QTc interval of more than 470 msec at study entry, and patients
with congenital long QTc syndrome.
- Active autoimmune disease
We found this trial at
2
sites
Atlanta, Georgia 30342
Principal Investigator: Tobey MacDonald, MD
Phone: 404-785-6011
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Augusta, Georgia 30912
Principal Investigator: Theodore Johnson, MD
Phone: 706-721-2154
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