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| Diagnosis | Ewing Sarcoma, Solid Tumors, Rhabdoid Tumor, Rhabdomyosarcoma, Neuroblastoma, Medulloblastoma, Diffuse Intrinsic Pontine Glioma | Study Status | Closed to enrollment |
| Phase | II |
| Age | 2 Years to 20 Years | Randomisation | YES |
| Line of treatment | Disease relapse or progression |
| Routes of Treatment Administration | Drug: Palbociclib (Oral)
Chemotherapy with Temozolomide (Oral or Intravenous (IV)); Irinotecan (Intravenous (IV)) |
| Last Posted Update | 2024-03-19 |
| ClinicalTrials.gov # | NCT03709680 |
International Sponsor
Sponsor: Pfizer
Collaborator: Children's Oncology Group (COG)Principal Investigators for Canadian Sites
CHU Ste-Justine - Dr. Monia Marzouki
The Hospital for Sick Children - Dr. Daniel Morgenstern
Alberta CH - Dr. Victor Lewis
Stollery Children's Hospital - Centres
Medical contact
Dr. Henrique Bittencourt
Dr. Monia Marzouki
Dr. Sebastien Perreault (neuro-onc)
Social worker/patient navigator contact
Marie-Claude Charrette
Clinical research contact
Marie Saint-Jacques
Medical contact
Dr. Victor Lewis
Social worker/patient navigator contact
Wendy Pelletier
Clinical research contact
Debra Rich
Medical contact
Dr. Sarah McKillop
Dr. Sunil Desai
Social worker/patient navigator contact
Danielle Sikora
Michelle Woytiuk
Jaime Hobbs
Clinical research contact
Amanda Perreault
Study Description
This trial studies the combination of a study drug called palbociclib with chemotherapy in children with solid tumors that have come back or not responded to standard treatment. Throughout this trial, the study team will observe how the drug is moving through your body and how your body is responding to the drug. The study team will also do a series of tests to study whether or not the drug is effective.
Inclusion Criteria
- Patient must be between 2 years to 20 years old at time of treatment
- Must have measurable disease of a solid tumour that has come back or has not responded to previous standard treatment
- For Phase 2 part, must have a diagnosis of Ewing sarcoma specifically
- Must be willing and able to comply with scheduled visits, treatment plan, laboratory tests and other procedures related to the study
- Patient must be able to be up and about more than 50% of their waking hours
- For patients of child bearing potential, they must not be pregnant or get pregnant during the course of the study
Other inclusion and exclusion criteria may apply and will be reviewed by your team
