Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Brain Tumor, Pediatric
  • Brain Cancer
  • Brain Tumor
  • Brain Tumor Recurrent
  • Brain Tumor, Refractory
  • CNS Cancer
  • CNS Neoplasm
  • Medulloblastoma, Non-WNT/Non-SHH, Group 4
  • CNS Tumor
  • Medulloblastoma
  • Medulloblastoma Recurrent
  • Medulloblastoma, Non-WNT/Non-SHH
  • Medulloblastoma, Non-WNT/Non-SHH, Group 3
Type
Interventional
Phase
Phase 1
Design
Allocation: Non-RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 1 years and 24 years
Gender
Both males and females

Description

Participants will be stratified by the biological characteristics of their tumor to one of two treatment strata: STRATUM A Combination Treatment: prexasertib and cyclophosphamide Patient population: Participants with recurrent/refractory Group 3 and Group 4 (G3/G4) medulloblastoma, recurrent/refract...

Participants will be stratified by the biological characteristics of their tumor to one of two treatment strata: STRATUM A Combination Treatment: prexasertib and cyclophosphamide Patient population: Participants with recurrent/refractory Group 3 and Group 4 (G3/G4) medulloblastoma, recurrent/refractory sonic hedgehog (SHH) medulloblastoma and medulloblastoma participants with Indeterminate molecular subgroup STRATUM B Combination Treatment: prexasertib and gemcitabine Patient population: Participants with recurrent/refractory Group 3 and Group 4 medulloblastoma Participants with a diagnosis of G3/G4 medulloblastoma who qualify for both treatment strata will be assigned per slot availability as well as institutional PI preference. If slots are available in both stratum A and stratum B, patients will be assigned to the dose level nearest completion. The Rolling 6 design will be used separately in each stratum to estimate the maximum tolerated dose (MTD) or recommended phase two dose (RP2D). Therapy will be administered in cycles of 28 days and may be continued for up to 24 months (26 cycles) in the absence of disease progression or unacceptable toxicity. Participants will receive doublet therapy in cycles of 28 days. The dose-limiting toxicity (DLT)-evaluation period will consist of the first cycle until day 1 criteria of cycle 2 has been met. Participants will be evaluated at least once a week during the DLT-evaluation period and at regular intervals thereafter. Standard tests (i.e. physical exams, blood tests, and disease evaluations) will be undertaken at regular intervals. Research-associated evaluations (i.e. pharmacokinetic studies, etc.) will also be carried out during therapy. Treatment may be continued for up to 2 years in the absence of disease progression or unacceptable toxicity.

Tracking Information

NCT #
NCT04023669
Collaborators
Eli Lilly and Company
Investigators
Principal Investigator: Giles W. Robinson, MD St. Jude Children's Research Hospital