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.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Flavored, Oral Irinotecan VAL-413 (Orotecan®) Given With Temozolomide for Treatment of Recurrent Pediatric Solid Tumors
At a glance
Conditions
Where it's being run
11 sites across 9 statesStudy leadership
- 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
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
What this trial measures
- 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