RecruitingMedulloblastoma

DFMO as Maintenance Therapy for Molecular High/Very High Risk and Relapsed Medulloblastoma

Eligible age

Up to 21 yrs

Accepts

All genders

Locations

16 states

Healthy volunteers

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About this study

Difluoromethylornithine (DFMO) will be used in an open label, multicenter, study as Maintenance Therapy for Molecular High Risk/Very High Risk and Relapsed/Refractory Medulloblastoma.

Sponsor: Giselle Sholler

You may qualify if…

✓ 1. Age: 0-21 years of age at diagnosis
✓ 2. Pathology All patients must either have a pathologically confirmed diagnosis of medulloblastoma with molecular grouping identified by either Nanostring or methylation profiling.
✓ Cohort 1- Molecular High Risk:
✓ Metastatic non-MYC amplified Group 3
✓ Metastatic Group 4
✓ Metastatic non-WNT/non-SHH (Must be non-MYC amplified)
✓ Cohort 2- Molecular Very High Risk
✓ Metastatic OR MYCN amplified OR TP53 mutant non-infant (\>3 yrs) SHH

You may not qualify if…

✕ 1. BSA of \<0.25 m2
✕ 2. Metastatic disease outside of CNS
✕ 3. Relapsed/refractory patients who are radiation-naïve and age 5 years or older at time of enrollment
✕ 4. Investigational Drugs: Subjects who are currently receiving another investigational drug are excluded from participation.
✕ 5. Anti-cancer Agents: Subjects who are currently receiving other anticancer agents are not eligible. Subjects must have fully recovered from the hematological and bone marrow suppression effects of prior chemotherapy.
✕ 6. Infection: Subjects who have an uncontrolled infection are not eligible until the infection is judged to be well controlled in the opinion of the investigator.
✕ 7. Subjects who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study, or in whom compliance is likely to be suboptimal, should be excluded.