🏛️ Verified NIH Record • Updated 2026-07-28

Flavored, Oral Irinotecan VAL-413 (Orotecan®) Given With Temozolomide for Treatment of Recurrent Pediatric Solid Tumors (NCT04337177)

Pilot Pharmacokinetic Study of VAL-413 (Orotecan®) in Patients With Recurrent Pediatric Solid Tumors

🔵 Active, Not Recruiting Phase1 💊 Investigational Drug / Biologic Sponsor: Valent Technologies, LLC

🩺 Plain-English Summary (8th-Grade Level)

A pilot pharmacokinetic trial to determine the safety and efficacy of a flavored, orally administered irinotecan VAL-413 (Orotecan®) given with temozolomide for treatment of recurrent pediatric solid tumors including but not limited to neuroblastoma, rhabdomyosarcoma, Ewing sarcoma, hepatoblastoma and medulloblastoma

Who can join: Review the eligibility criteria below.

Location: Phoenix Children's Hospital — Phoenix, Arizona

Age range: 1 Year to 30 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria ↗

📍 All Participating Trial Locations (11 Sites)

  • Phoenix Children's Hospital — Phoenix, Arizona
  • UCSF, Mission Bay - Benioff Children's Hospital — San Francisco, California
  • Children's National Research Institute - Children's National Hospital — Washington D.C., District of Columbia
  • Children's Healthcare of Atlanta - Arthur M. Blank Hospital — Atlanta, Georgia
  • Indiana University School of Medicine, Riley Hospital for Children — Indianapolis, Indiana
  • Washington University - St. Louis — St Louis, Missouri
  • University of North Carolina at Chapel Hill - North Carolina Cancer Hospital — Chapel Hill, North Carolina
  • Atrium Health Levine Children's Hospital - Carolinas Medical Center — Charlotte, North Carolina
  • Duke University Children's Hospital and Health Center — Durham, North Carolina
  • Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio
  • Sarah Cannon Research Institute, Pediatric Hematology & Oncology — Nashville, Tennessee

💰 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.

Explore by condition: All Solid Tumors clinical trials

💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗