Palbociclib, Irinotecan, and Temozolomide in Ewing Sarcoma

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The purpose of the Phase 2 portion of this study is to evaluate the safety and efficacy of the study drug called palbociclib when given in combination with two other drugs (temozolomide and irinotecan) in patients with Ewing sarcoma and when given in combination with topotecan and cyclophosphamide in patients with neuroblastoma.

Who Do I Contact?

If you are interested in participating in the study or want to learn more please contact our study team at cancertrials [at] chop.edu or 267-425-5544.

Eligibility & Criteria

IRB #:
19-016357
Official Title:
Phase 1/2 Study to Evaluate Palbociclib (Ibrance®) in Combination with Irinotecan and Temozolomide and/or in Combination with Topotecan and Cyclophosphamide in Pediatric Patients with Recurrent or Refractory Solid Tumors (ADVL1921)
Study Phase:
Phase II
Eligible Age Range:
2 - 20 Years
Gender:
All
Study Categories:

Visit Criteria

As a participant in the research, you will:

  • Receive infusions of cyclophosphamide and topotecan or irinotecan and temozolomide (temozolomide may be taken by mouth)
  • Be given palbociclib to take in the clinic and at home
  • Complete frequent clinic visits at CHOP
  • Have frequent blood tests, including research blood tests to measure palbociclib levels (pharmacokinetic studies) and to measure hormone levels
  • Have periodic EKGs
  • Have periodic imaging performed to evaluate your response to treatment and to mesure your bone density (DEXA scans) 
  • Be asked to complete questionnaires and medication diaries
  • Be asked if we can submit previously obtained samples of your tumor to the sponsor; this will not require new biopsy

 

Leader
Theodore W. Laetsch

Theodore Laetsch, MD