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Palbociclib, Irinotecan, and Temozolomide in Ewing Sarcoma
This study is now recruiting.
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.
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
Visit Criteria
This study will enroll male and female patients between 2 and 20 years of age with histologically confirmed relapsed or refractory Ewing sarcoma. All patients will receive temozolomide and irinotecan and some will be randomized to also receive Palbociclib while others will not receive the study drug. Study visits will also include the following assessments: tumor submission, blood samples to measure hormones and chemistries and to assess how the body handles the drug (pharmacokinetic studies), electrocardiograms, DEXA scans, xrays, and completion of questionnaires and patient diaries. In addition to the study visits, subjects will need to come to CHOP frequently for assessments as part of regular cancer care. This includes follow-up visits, blood draws, and scans to monitor any side effects and tumor response.
Leader
