Tocilizumab in Children With ACP

Part of paid clinical trials in Aurora, Colorado.

Sponsor
University of Colorado, Denver
Study ID
NCT03970226
Phase
EARLY_PHASE1
Status
Active Not Recruiting

Conditions

  • Adamantinomatous Craniopharyngioma

Eligibility Criteria

Sex
ALL
Age
2 Years - 21 Years
Healthy Volunteers
Not accepted

Interventions

  • Tocilizumab — DRUG
    Phase 0: One dose of tocilizumab prior to surgery Feasibility phase: Tocilizumab administered every 2 weeks for up to 13 cycles (approximately 1 year).

Study Details

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.

Key Dates

Start date
Sep 16, 2019
Status verified
Feb 2026
Primary completion
May 26, 2024
Completion
May 31, 2027

Study Design

Enrollment
9 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Tocilizumab Administration: Phase 0
    In Phase 0, patients will receive one dose of tocilizumab prior to surgery.
  • Experimental: Tocilizumab Administration: Feasibility Phase
    During the Feasibility Phase, patients will receive tocilizumab every 2 weeks for up to 13 cycles (approximately 1 year). Patients will be followed for up to 5 years.

Primary Outcome Measure

Phase 0: Presence of Tocilizumab and Metabolites [ Time Frame: Within 4 to 8 hours of administration of tocilizumab ]

Locations (1)

FacilityCityStateZIPSite coordinators
Children's Hospital ColoradoAuroraColorado80045-

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By research site
Children's Hospital Colorado· Aurora, CO

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