RecruitingPhase 1NCT04337177

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

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


Sponsor

Valent Technologies, LLC

Enrollment

20 participants

Start Date

Oct 25, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 1 YearMax Age: 30 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a flavored, liquid oral form of irinotecan (brand name Orotecan) given together with temozolomide — both cancer medicines — for children and young adults with solid tumors or brain tumors that have come back after prior treatment. The study is looking at whether this easier-to-swallow oral version is safe and practical. **You may be eligible if...** - You are between 1 and 30 years old - You have a solid tumor or brain tumor confirmed by biopsy (either at original diagnosis or at relapse) - Your cancer has come back and there is no known cure or effective standard treatment remaining - You are physically active enough to do basic activities (Karnofsky/Lansky score of at least 50) - You have recovered from side effects of prior treatments - You agree to use effective contraception if of reproductive age **You may NOT be eligible if...** - Your cancer progressed while you were actively on irinotecan or temozolomide - You are still experiencing significant side effects from your last treatment - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGVAL-413

a flavored preparation of orally administered irinotecan

DRUGTemozolomide

alkylating oral chemotherapy agent used to treatment brain cancers


Locations(8)

UCSF, Mission Bay - Benioff Children's Hospital

San Francisco, California, United States

Children's National Research Institute - Children's National Hospital

Washington D.C., District of Columbia, United States

Indiana University School of Medicine, Riley Hospital for Children

Indianapolis, Indiana, United States

University of North Carolina at Chapel Hill - North Carolina Cancer Hospital

Chapel Hill, North Carolina, United States

Atrium Health Levine Children's Hospital - Carolinas Medical Center

Charlotte, North Carolina, United States

Duke University Children's Hospital and Health Center

Durham, North Carolina, United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Sarah Cannon Research Institute, Pediatric Hematology & Oncology

Nashville, Tennessee, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT04337177


Related Trials