🏛️ 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 ChecklistFull 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.
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- Study of the Effect of Rifampicin on the Pharmacokinetics (PK) of Multiple Doses of Cediranib in Patients With Solid Tumours — Edmonton, Alberta
- Study of Anti-CEACAM5 ADC M9140 in Participants With Advanced Solid Tumors (PROCEADE PanTumor) — Santa Monica, California
- A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial — Porto Alegre, Rio Grande do Sul
- Safety, Tolerability, and Immunogenicity of mRNA-4157 Alone and in Combination in Participants With Solid Tumors — Los Angeles, California
Explore by condition: All Solid Tumors 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.