Tocilizumab in Children With ACP

Description

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.

Conditions

Adamantinomatous Craniopharyngioma

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Study Overview

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Study Details

Study overview

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.

A Phase 0/Feasibility Trial of Tocilizumab in Children and Adolescents With Newly- Diagnosed or Recurrent/Progressive Adamantinomatous Craniopharyngioma

Tocilizumab in Children With ACP

Condition
Adamantinomatous Craniopharyngioma
Intervention / Treatment

-

Contacts and Locations

Aurora

Children's Hospital Colorado, Aurora, Colorado, United States, 80045

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Age: ≥ 2 years and \< 21 years
  • 2. Subjects may have received prior tocilizumab or other IL6 or IL6R inhibitor
  • 3. Organ Function Requirements
  • 1. Adequate bone marrow function defined as:
  • * Platelet count ≥100,000/μl (transfusion independent)
  • * Absolute neutrophil count (ANC) ≥1500/μl
  • 2. Adequate renal function defined as:
  • * Creatinine clearance or radioisotope GFR ≥70 ml/min/1.73 m2 or
  • * A serum creatinine based on age/gender as follows: (Age, Male, Female) 3 to \< 6 years, 0.8, 0.8; 6 to \< 10 years, 1, 1; 10 to \< 13 years, 1.2, 1.2; 13 to \< 16 years, 1.5, 1.4; 16 years to \< 18 years, 1.7, 1.4
  • 3. Adequate liver function defined as:
  • * SGOT (AST) and SGPT (ALT) \<1.5x ULN for age
  • 4. Subjects must meet one of the following performance scores:
  • 1. ECOG performance status scores of 0, 1, or 2;
  • 2. Karnofsky score of ≥60 for patients \> 16 years of age; or
  • 3. Lansky score of ≥60 for patients ≤16 years of age
  • 5. Subjects of childbearing or child fathering potential must be willing to use a medically acceptable form of birth control, which includes abstinence, while being treated on this study.
  • 6. Informed consent and assent obtained as appropriate.
  • 1. Pregnant or breastfeeding
  • 2. Uncontrolled intercurrent illness including, but not limited to:
  • 1. ongoing or active infection (including active tuberculosis)
  • 2. symptomatic congestive heart failure
  • 3. unstable angina pectoris
  • 4. cardiac arrhythmia
  • 5. psychiatric illness/social situations that would limit compliance with study requirements are not eligible.
  • 3. Known hypersensitivity or history of anaphylaxis to tocilizumab
  • 4. Received any live vaccinations within 3 months prior to start of therapy
  • 5. Evidence of metastatic disease or other cancer
  • 6. Inability to return for follow up visits or obtain required follow-up studies to assess toxicity of therapy

Ages Eligible for Study

2 Years to 21 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Colorado, Denver,

Margaret Macy, MD, PRINCIPAL_INVESTIGATOR, Children's Hospital Colorado

Study Record Dates

2025-12