Summary

Eligibility
for people ages up to 21 years (full criteria)
Location
at Oakland, California and other locations
Dates
study started
completion around
Principal Investigator
by Caroline Hastings
Headshot of Caroline Hastings
Caroline Hastings

Description

Summary

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.

Official Title

Phase II Trial of Eflornithine/DFMO as Maintenance Therapy for Molecular High Risk/Very High Risk and Relapsed/Refractory Medulloblastoma

Details

In this study subjects will receive 730 Days of oral difluoromethylornithine (DFMO) at a dose of 2500 mg/m2 BID on each day of study.

Subjects will be evaluated in 3 Cohorts:

Cohort 1: Molecular High Risk Medulloblastoma Cohort 2: Molecular Very High Risk Medulloblastoma Cohort 3: Relapsed/Refractory Medulloblastoma

A total of 118 subjects across all cohorts will be enrolled to ensure that there will be 107 evaluable subjects (32-39 per cohort)

Keywords

Medulloblastoma, Eflornithine, Difluoromethylornithine, Difluoromethylornithine (DFMO)

Eligibility

Locations

  • UCSF Benioff Children's Hospital Oakland- accepting new patients
    Oakland California 94609 United States
  • Rady Children's Hospital accepting new patients
    San Diego California 92123 United States

Lead Scientist at UCSF

  • Caroline Hastings
    Dr. Caroline Hastings is a Professor of Pediatrics and is specialty boarded in Pediatric Hematology Oncology. She has been at Children's Hospital Oakland and now UCSF since completion of her training in 1992. Her longevity in the group has allowed for personal and professional growth and development of long-term relationships with her patients.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Giselle Sholler
Links
Beat Childhood Cancer Consortium website
ID
NCT04696029
Phase
Phase 2 Medulloblastoma Research Study
Study Type
Interventional
Participants
Expecting 118 study participants
Last Updated