Tocilizumab in Children With ACP

Korábbi kezelés

• Received any live vaccinations within 3 months prior to start of therapy
• Inability to return for follow up visits or obtain required follow-up studies to assess toxicity of therapy

Más betegség

• Uncontrolled intercurrent illness including, but not limited to:
  • ongoing or active infection (including active tuberculosis)
  • symptomatic congestive heart failure
  • unstable angina pectoris
  • cardiac arrhythmia
  • psychiatric illness/social situations that would limit compliance with study requirements are not eligible.
• Known hypersensitivity or history of anaphylaxis to tocilizumab
• Evidence of metastatic disease or other cancer

Egyéb

• Pregnant or breastfeeding

• Phase 0 Eligibility:
• 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
  • Feasibility Eligibility:
• 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
  • Progressive disease for eligibility purposes will be defined as follows: Solid disease: any growth deemed progression based on discretion of the investigator regardless of timing from RT Cystic disease: must be at least 6 months from last day of RT. Patients demonstrating isolated cyst growth >6 months after RT must show a continued increase in the cystic component on two serial MRI scans performed at least 4 weeks apart OR at least partial reaccumulation of the cyst following one or more cyst aspirations.
  • Newly diagnosed, by histology or imaging ACP with unresectable residual cystic and/or solid disease that is measurable in 2 dimensions
• Subjects who participated in the Phase 0 portion and meet eligibility, may enroll in the Feasibility Phase of the study once open.
  • Overall Study Inclusion Criteria:
• Age: ≥ 2 years and < 21 years
• Subjects may have received prior tocilizumab or other IL6 or IL6R inhibitor
• Organ Function Requirements
  • Adequate bone marrow function defined as:
  • Platelet count ≥100,000/μl (transfusion independent)
  • Absolute neutrophil count (ANC) ≥1500/μl
  • 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
  • Adequate liver function defined as:
  • SGOT (AST) and SGPT (ALT) <1.5x ULN for age
• Subjects must meet one of the following performance scores:
  • ECOG performance status scores of 0, 1, or 2;
  • Karnofsky score of ≥60 for patients > 16 years of age; or
  • Lansky score of ≥60 for patients ≤16 years of age
• 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.
• Informed consent and assent obtained as appropriate.