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

{ "VAL-413 (Orotecan®) and Temozolomide for Recurrent Pediatric Solid Tumors", "This study is testing a new flavored, oral form of irinotecan called VAL-413 (Orotecan®) alongside temozolomide for children and young adults (ages 1 to 30) with recurrent solid tumors. This includes cancers like neuroblastoma, rhabdomyosarcoma, Ewing sarcoma, and hepatoblastoma. The main goal is to find the safest and most effective dose of Orotecan® when given with temozolomide. Researchers will look at how safe the treatment is and how well it works over about 17 months. This is a pilot study, meaning it's an early step to see if this combination treatment is promising. The study is currently unclear on its recruitment status and plans to enroll up to 20 patients.", "design": "This is an interventional study, meaning participants will receive a specific treatment. It aims to enroll up to 20 patients.", "commitments": "You would receive VAL-413 (Orotecan®) and temozolomide orally for 5 days every 21 days, potentially for up to 17 cycles. You will have medical histories, physical exams, and blood tests at the start of each treatment cycle.", "compensation": "Not stated in the trial record.", "follow_up": "The primary endpoint for this study is measured at 17 months.", }

Study design
Not specified.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Not specified.

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NCT04337177

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

Active, Not Recruiting
PHASE1Ages 1–30InterventionalTreatment
Valent Technologies, LLC
~20 participants
Updated 2026-07-30 on ClinicalTrials.gov
What's tested:VAL-413Temozolomide

At a glance

Recruiting sites
0 of 11 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Recommended Phase II Dose (RP2D)
Measured over 17 months
Solid Tumors
Neuroblastoma
Rhabdomyosarcoma
Ewing Sarcoma
Hepatoblastoma
Medulloblastoma
11 sites across 9 states
North Carolina3
Arizona1
California1
District of Columbia1
Georgia1
Indiana1
Missouri1
Ohio1
  • Lars Wagner, M.D. · PRINCIPAL_INVESTIGATOR · Children's Hospital Medical Center, Cincinnati
  • Michael Deel, M.D. · PRINCIPAL_INVESTIGATOR · Children's Hospital Medical Center, Cincinnati
  • Meghann McManus, D.O. · PRINCIPAL_INVESTIGATOR · Sarah Cannon Research Institute, Pediatric Hematology & Oncology
  • Erin Trovillion, M.D. · PRINCIPAL_INVESTIGATOR · Atrium Health Levine Children's Hospital - Carolinas Medical Center
  • Patrick Thompson, M.D. · PRINCIPAL_INVESTIGATOR · UNC Chapel Hill - North Carolina Cancer Hospital
  • Aerang Kim, M.D. · PRINCIPAL_INVESTIGATOR · Children's National Hospital - Washington, DC
  • Kieuhoa Vo, M.D. · PRINCIPAL_INVESTIGATOR · UCSF - Mission Bay, Benioff Children's Hospital
  • Kyle Jackson, M.D. · PRINCIPAL_INVESTIGATOR · Indiana University School of Medicine, Riley Hospital for Children
  • William Thomas Cash, M.D. · PRINCIPAL_INVESTIGATOR · Children's Healthcare of Atlanta - Arthur M. Blank Hospital
  • Alok Kothari, M.D. · PRINCIPAL_INVESTIGATOR · Phoenix Children's Hospital
  • Mia Weiss, M.D. · PRINCIPAL_INVESTIGATOR · Washington University School of Medicine

This trial hasn't published a contact. View it on ClinicalTrials.gov

  • Recommended Phase II Dose (RP2D)17 months

    To establish the recommended Phase II dose of a flavored preparation of orally administered irinotecan VAL-413 (Orotecan®) when given in combination with temozolomide for 5 consecutive days