Tocilizumab in Children With ACP (NCT03970226) | Clinical Trial Compass
Active — Not RecruitingEarly Phase 1
Tocilizumab in Children With ACP
United States9 participantsStarted 2019-09-16
Plain-language summary
This study will be conducted in two phases. The first phase (phase 0) will be looking at patients with new or recurrent/ progressed craniopharyngioma tumors. These patients will be given one dose of tocilizumab before they have SOC surgery of their tumor. The objective of this phase is to see if drug reaches the tumor. If phase 0 is favorable and shows that drug is penetrating the tumor, the second phase of the study (feasibility phase) will open. Both phases will remain open concurrently and patients will be able to enroll on the Phase 0 then "roll over" and enroll on the feasibility phase. During the feasibility phase patients will be administered tocilizumab every two weeks for up to 13 cycles (approximately 1 year). Patients will be followed for up to 5 years in the feasibility phase.
Who can participate
Age range2 Years – 21 Years
SexALL
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Inclusion criteria
✓. Tumor biopsy/resection and/or cyst aspiration planned for the clinical care of the patient independent of study participation by the treating pediatric neurosurgeon and neuro-oncologist
✓. Must meet one of the following criteria:
✓. Presumed craniopharyngioma based on imaging features and best judgement of treating medical team (if newly diagnosed)
✓. Previous histologically confirmed ACP that has progressed or recurred at the time of enrollment
✓. Must meet one of the following criteria:
✓. Recurrent or progressive\* ACP treated with surgery alone without radiation
✓. Recurrent or progressive\* ACP treated with surgery and radiation
✓. Newly diagnosed, by histology or imaging ACP with unresectable residual cystic and/or solid disease that is measurable in 2 dimensions
Exclusion criteria
✕. Pregnant or breastfeeding
What they're measuring
1
Phase 0: Presence of Tocilizumab and Metabolites
Timeframe: Within 4 to 8 hours of administration of tocilizumab
2
Feasibility Phase: Toxicity Profile
Timeframe: Start of study to end of study, up to 5 years