ACTIVE_NOT_RECRUITING

Tocilizumab in Children With ACP

Conditions

Adamantinomatous Craniopharyngioma Phase 0 Feasibility Tocilizumab

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2019-09-16

Study Completion:2025-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT03970226

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.

Ages Eligible for Study:2 Years to 21 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT

Inclusion Criteria	Exclusion 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	Pregnancy or breastfeeding Severe psychiatric disorders Active substance abuse Unstable medical conditions Inability to comply with study requirements

Inclusion Criteria

Exclusion 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

Pregnancy or breastfeeding
Severe psychiatric disorders
Active substance abuse
Unstable medical conditions
Inability to comply with study requirements

Contacts and Locations

Principal Investigator

Margaret Macy, MD

PRINCIPAL_INVESTIGATOR

Children's Hospital Colorado

Study Locations (Sites)

Children's Hospital Colorado

Aurora, Colorado, 80045

United States

Collaborators and Investigators

Sponsor: University of Colorado, Denver

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-09-16

Study Completion Date2025-12

Study Record Updates

Study Start Date2019-09-16

Study Completion Date2025-12

Terms related to this study

Keywords Provided by Researchers

Phase 0
Feasibility
Tocilizumab

Additional Relevant MeSH Terms

Adamantinomatous Craniopharyngioma