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

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

Conditions

• Solid Tumors
• Neuroblastoma
• Rhabdomyosarcoma
• Ewing Sarcoma
• Hepatoblastoma
• Medulloblastoma

Interventions

DRUG

VAL-413

a flavored preparation of orally administered irinotecan

DRUG

Temozolomide

alkylating oral chemotherapy agent used to treatment brain cancers

Sponsors & Collaborators

• Valent Technologies, LLC

  lead INDUSTRY

Principal Investigators

• Lars Wagner, M.D. · Children's Hospital Medical Center, Cincinnati

• Michael Deel, M.D. · Children's Hospital Medical Center, Cincinnati

• Meghann McManus, D.O. · Sarah Cannon Research Institute, Pediatric Hematology & Oncology

• Javier Oesterheld, M.D. · Atrium Health Levine Children's Hospital - Carolinas Medical Center

• Patrick Thompson, M.D. · UNC Chapel Hill - North Carolina Cancer Hospital

• Aerang Kim, M.D. · Children's National Hospital - Washington, DC

• Kieuhoa Vo, M.D. · UCSF - Mission Bay, Benioff Children's Hospital

• Kyle Jackson, M.D. · Indiana University School of Medicine, Riley Hospital for Children

• William Thomas Cash, M.D. · Children's Healthcare of Atlanta - Arthur M. Blank Hospital

• Alok Kothari, M.D. · Phoenix Children's Hospital

• Mia Weiss, M.D. · Washington University School of Medicine

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

1 Year

Max Age

30 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-10-25

Primary Completion

2026-06-30

Completion

2026-06-30

FDA Drug

Yes

Countries

• United States

Study Locations