Study Of Palbociclib Combined With Chemotherapy In Pediatric Patients With Recurrent/Refractory Solid Tumors (NCT03709680)
PHASE 1/2 STUDY TO EVALUATE PALBOCICLIB (IBRANCE®) IN COMBINATION WITH IRINOTECAN AND TEMOZOLOMIDE OR IN COMBINATION WITH TOPOTECAN AND CYCLOPHOSPHAMIDE IN PEDIATRIC PATIENTS WITH RECURRENT OR REFRACTORY SOLID TUMORS
🩺 Plain-English Summary (8th-Grade Level)
A study to learn about safety and find out maximum tolerable dose of palbociclib given in combination with chemotherapy (temozolomide with irinotecan or topotecan with cyclophosphamide) in children, adolescents and young adults with recurrent or refractory solid tumors (phase 1). Neuroblastoma tumor specific cohort to further evaluate antitumor activity of palbociclib in combination with topotecan and cyclophosphamide in children, adolescents, and young adults with recurrent or refractory neuroblastoma. Phase 2 to learn about the efficacy of palbociclib in combination with irinotecan and temozolomide when compared with irinotecan and temozolomide alone in the treatment of children, adolescents, and young adults with recurrent or refractory Ewing sarcoma (EWS).
Who can join: Review the eligibility criteria below.
Location: University of Alabama at Birmingham/Children's of Alabama — Birmingham, Alabama
Age range: 2 Years to 20 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (101 Sites)
Showing the first 25 of 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.
More studies in Ewing Sarcoma
- Liquid Biopsy in Ewing Sarcoma and Osteosarcoma as a Prognostic And Response Diagnostic: LEOPARD — Los Angeles, California
- RAPID: Phase 2 Platform Trial Of Promising Drugs For AYA Patients With R/R Ewing Sarcoma & DSRCT — Houston, Texas
- EWSR1 Immunotherapy in Ewing Sarcoma and DSRCT — Cleveland, Ohio
- Lurbinectedin in FET-Fused Tumors — Los Angeles, California
- Phase 1 Study of INBRX-109 in Subjects With Locally Advanced or Metastatic Solid Tumors Including Sarcomas — Scottsdale, Arizona
Explore by condition: All Ewing Sarcoma clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.