Pilot Pharmacokinetic Study of VAL-413 (Orotecan®) in Patients With Recurrent Pediatric Solid Tumors
Valent Technologies, LLC
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
Description
Up to 20 patients ≥ 1 year of age or ≤ 30 years of age with recurrent pediatric solid tumors will be enrolled. During the first cycle of treatment, each patient will receive 4 daily doses of VAL-413 (Orotecan®) and one daily dose of the intravenous preparation of irinotecan taken orally (IRN-IVPO), together with 5 days of concurrent temozolomide. During all subsequent cycles, only Orotecan® will be given with temozolomide in 5 day courses administered every 21 days as tolerated. The dosing regimen in this study will be Temozolomide at 100 mg/m2/day with Orotecan® at either 90 or 110mg/m2/day,…
Eligibility
- Age range
- 1–30 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Patients must be 1 year of age to ≤ 30 years of age at the time of study entry. 2. Patients must have had histologic verification of a solid tumor or CNS tumor at either original diagnosis or relapse. 3. Measurable or evaluable disease is not required for enrollment on this safety/feasibility study. 4. Patient's current disease state must be one for which there is no known curative therapy or therapy proven to prolong survival with an acceptable quality of life or for which irinotecan and/or temozolomide are acceptable therapeutic options based on existing standard of c…
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 HospitalSan Francisco, California
- Children's National Research Institute - Children's National HospitalWashington D.C., District of Columbia
- Indiana University School of Medicine, Riley Hospital for ChildrenIndianapolis, Indiana
- University of North Carolina at Chapel Hill - North Carolina Cancer HospitalChapel Hill, North Carolina
- Atrium Health Levine Children's Hospital - Carolinas Medical CenterCharlotte, North Carolina
- Duke University Children's Hospital and Health CenterDurham, North Carolina