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Through this multi-center Children’s Oncology Group study, researchers are evaluating palbociclib, known by the trade name IBRANCE®, in combination with chemotherapy with temozolomide (TMZ) and irinotecan (IRN) in children, adolescents, and young adults with recurrent or refractory solid tumors. Researchers will be evaluating how the body processes the drug, side effects, therapeutic effects, and drug tolerance to determine optimal dosage levels.
Subject to certain exclusion criteria, this study is enrolling patients who have a recurrent and/or refractory malignant solid tumor for which there is no standard of care treatment.
Males and Females: 2 to 20 years of age
Participants will take the study drug in capsule or liquid form once daily for days 1-14 of each 21-day cycle. TMZ and IRN will be given daily on days 1 to 5 and require visits to the study doctor for intravenous infusion of IRN. Various other tests and imaging will be done at intervals specified by the protocol. Participants may remain in the study for up to 2 years providing their tumor has not advanced, that they are not having severe side effects.
Visits: On days 1-5 of each 21-day cycle, with additional evaluations during cycle 1 of therapy
Duration: Up to 2 years
Children’s Oncology Group (ADVL1921)
Study Description at the National Institutes of Health
Cancer and Blood Disorder Research
Children’s Oncology Group CureSearch
Andrew Bukowinski, MD
For more information about the study or enrollment, please contact:
Sharon Dibridge, Clinical Research Coordinator
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One Children’s Hospital Way
4401 Penn Ave.
Pittsburgh, PA 15224
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