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

ConditionRefractory 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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

Eribulin
Drug
Given by vein (IV)
Irinotecan
Drug
Given by vein (IV)
Temozolomide
Drug
Given by PO

Treatment groups

48 Participants

are divided into 4 treatment groups

Group A: Arm A: Dose expansion-Ewings sarcomaExperimental treatment 3 interventions

Group B: Arm B: Dose expansion -RhabdomyosarcomaExperimental treatment 3 interventions

Group C: Arm C: Dose expansion- other solid tumor histologiesExperimental treatment 3 interventions

Group D: Arm D: Dose finding levels 0,-1 and -2Experimental treatment 3 interventions

Trial outcomes

Primary outcomes

Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

Time frame

through study completion; an average of 1 year

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

M.D. Anderson Cancer Center

Lead sponsor

Source ClinicalTrials.gov

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