Spots Global Cancer Trial Database for Tocilizumab in Children With ACP
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Trial Identification
Brief Title: Tocilizumab in Children With ACP
Official Title: A Phase 0/Feasibility Trial of Tocilizumab in Children and Adolescents With Newly- Diagnosed or Recurrent/Progressive Adamantinomatous Craniopharyngioma
Study ID: NCT03970226
Conditions
Interventions
Study Description
Brief 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.
Detailed Description:
Keywords
Eligibility
Minimum Age: 2 Years
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Children's Hospital Colorado, Aurora, Colorado, United States
Contact Details
Name: Kathleen Dorris, MD
Affiliation: University of Colorado, Denver
Role: PRINCIPAL_INVESTIGATOR
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