Trials / Available
AvailableNCT03581240
An Intermediate Expanded Use Trial of DFMO
- Status
- Available
- Phase
- —
- Study type
- Expanded Access
- Enrollment
- —
- Sponsor
- Giselle Sholler · Academic / Other
- Sex
- All
- Age
- 0 Years – 30 Years
- Healthy volunteers
- —
Summary
To provide DFMO in an expanded use setting to subjects with relapsed rare tumors with increased LIN28 expression or MYCN amplification or up regulation of ornithine decarboxylase.
Conditions
- Neuroblastoma
- Medulloblastoma
- Typical Teratoid Rhabdoid Tumor
- Embryonal Tumor With Abundant Neuropil and True Rosettes
- Ependymoblastoma
- Medulloepithelioma
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | eflornithine HCl | In this study subjects without CNS disease will receive oral difluoromethylornithine (DFMO) at a dose of 500 to 1000 mg/m2 BID Subjects with CNS disease will receive a dose of 2500 mg/m2/dose BID in order to facilitate crossing into the CNS. |
Timeline
- First posted
- 2018-07-10
- Last updated
- 2026-02-20
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT03581240. Inclusion in this directory is not an endorsement.