A Phase Ib Trial of Eribulin in Combination With Irinotecan and Temozolamide in Children With Relapsed or Refractory Solid Tumors

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age1-25
SponsorM.D. Anderson Cancer Center

About this trial

To find the recommended dose of eribulin that can be given in combination with irinotecan and temozolomide to treat relapsed and/or refractory solid tumors.

Eligibility criteria

Qualifiers

Age: Patients must be > 1 year of age and ≤ 25 years of age at time of initiation of protocol therapy.

Diagnosis: Patients have a histologically or radiographically confirmed relapsed or refractory solid tumor.

Disease Status: Patients must have evaluable disease.

Patients may have CNS metastases at study entry, if they are previously treated or stable (defined by not requiring initation or increased steroids for 7 days).

Disqualifiers

Significant organ dysfunction, not meeting inclusion criteria.

Pediatric subjects who are considered wards of some entity

Pregnancy or Breast-Feeding

Pregnant or breast-feeding woman will not be entered on this study due to risks of fetal and teratogenic adverse events as seen in animal/human studies.

Trial design

Treatments tested in this trial

  • Eribulin
  • Irinotecan
  • Temozolomide

Treatment groups

48 Participants
are divided into 4 treatment groups

Sponsors and collaborators