Study Of Palbociclib Combined With Chemotherapy In Pediatric Patients With Recurrent/Refractory Solid Tumors (NCT03709680)

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

1. Histologically confirmed relapsed or refractory solid tumor as follows:
2. For dose escalation and dose determination parts: Histologically confirmed relapsed or refractory solid tumor (including CNS tumors but not lymphomas). Patients with Diffuse Intrinsic Pontine Glioma do not require histological only radiographic confirmed relapse to enroll.
3. For dose expansion and tumor specific cohorts: Histologically confirmed relapsed or refractory solid tumor including but not limited to EWS, rhabdoid tumor, rhabdomyosarcoma, neuroblastoma, and medulloblastoma. Patients with Diffuse Intrinsic Pontine Glioma do not require histological only radiographic confirmed relapse to enroll. EWS is not eligible for TOPO and CTX tumor-specific cohorts.
4. For randomized Phase 2 part: Histologically confirmed Ewing sarcoma at diagnosis or at relapse, with presence of EWSR1-ETS or FUS-ETS rearrangement. Histopathology confirmation of both EWSR1-ETS or FUS-ETS rearrangement partners is required OR availability of formalin fixed paraffin embedded (FFPE) tumor tissue sample for central testing. Patient must have relapsed or have refractory disease and at least evaluable disease in at least one site other than bone marrow that can be followed by imaging.
5. Age ≥2 and \<21 years at the time of study entry.
6. Lansky performance status ≥50% for patients ≤16 years of age, or Eastern Cooperative Oncology Group (ECOG) 0, 1 or 2 for patients \>16 years of age.
7. Adequate bone marrow function.
8. Absolute neutrophil count ≥1000/mm3;
9. Platelet count ≥75,000/mm3 (transfusion independent, no platelet transfusion in past 7 days prior study entry);
10. Hemoglobin ≥8.5 g/dL (transfusion allowed).
11. Adequate renal function: Serum creatinine level based on age/gender must within protocol specified limits.
12. Adequate liver function, including:

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (101 Sites)

• University of Alabama at Birmingham/Children's of Alabama — Birmingham, Alabama
• Phoenix Children's Hospital — Phoenix, Arizona
• MemorialCare Health System - Long Beach Medical Center — Long Beach, California
• Children's Hospital Los Angeles — Los Angeles, California
• Children's Hospital and Research Center at Oakland — Oakland, California
• Children's Hospital of Orange County — Orange, California
• Lucile Packard Children's Hospital — Palo Alto, California
• UCSF Medical Center — San Francisco, California
• University of California San Francisco, — San Francisco, California
• Children's Hospital Colorado — Aurora, Colorado
• Children's National Hospital — Washington D.C., District of Columbia
• UF Health Shands Hospital — Gainesville, Florida
• University of Florida College of Medicine — Gainesville, Florida
• Johns Hopkins All Children's Hospital — St. Petersburg, Florida
• Johns Hopkins All Children's Outpatient Care Center — St. Petersburg, Florida
• Johns Hopkins All Children's Hospital — Tampa, Florida
• Children's Healthcare of Atlanta at Egleston — Atlanta, Georgia
• Children's Healthcare of Atlanta at Scottish Rite — Atlanta, Georgia
• Children's Healthcare of Atlanta, Medical Office Building — Atlanta, Georgia
• Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago, Illinois
• Indiana University — Indianapolis, Indiana
• Norton Children's Hospital — Louisville, Kentucky
• Novak Center for Children's Health — Louisville, Kentucky
• Johns Hopkins University — Baltimore, Maryland
• University of Michigan Health System — Ann Arbor, Michigan

💰 Cost, Insurance & Patient Rights

• 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
• Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
• Voluntary Participation: You may withdraw at any time without affecting your standard medical care.