Flavored, Oral Irinotecan (VAL-413) Given With Temozolomide for Treatment of Recurrent Pediatric Solid Tumors
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Ewing Sarcoma
- Hepatoblastoma
- Medulloblastoma
- Neuroblastoma
- Rhabdomyosarcoma
- Solid Tumors
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: Non-RandomizedIntervention Model: Sequential AssignmentIntervention Model Description: Two different dose levels of VAL-413 will be studied in combination with fixed-dose temozolomide using a standard 3 + 3 phase I design. The first three patients will receive temozolomide in combination with VAL-413 at 90 mg/m2/day, which is the standard dose of irinotecan. If no dose-limiting toxicity (DLT) occurs during Cycle 1 in these patients, then subsequent patients will start Cycle 1 using a VAL-413 dose of 110 mg/m2/day. In the event the starting dose of 90 mg/m2/day is not tolerable due to toxicity, a lower starting dose of 75 mg/m2/day may be implemented.Masking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 1 years and 30 years
- Gender
- Both males and females
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 and one daily dose of the intravenous preparation of irinotecan taken orally (IRN-IVPO), together wit...
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 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 VAL-413 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 VAL-413 at either 90 or 110mg/m2/day, administered orally for 5 consecutive days at the beginning of every 21-day cycle. A single dose of IRN-IVPO will be substituted at the same dosage as VAL-413 during Cycle 1. Up to 17 cycles of treatment may be administered on this study. Data collected from this study will allow for an assessment of VAL-413 safety and efficacy. Interval medical histories, targeted physical exams, complete blood counts, and other laboratory and safety assessments will be performed at Day 1 of each treatment cycle for all study subjects. At baseline and during study, disease status will be assessed by appropriate clinical and imaging evaluation (CT, MRI, or PET) and using Response Evaluation Criteria in Solid Tumors (RECIST), or for patients with neuroblastoma, using International Neuroblastoma Response Criteria. In addition, a palatability survey will be conducted on Day 1 or Day 4 of the first cycle, which will allow patients to evaluate the taste of VAL-413. Serum samples will be collected at various time points on Days 1 and 4 during Cycle 1 to characterize and compare the pharmacokinetic profiles of VAL-413 and conventional irinotecan given orally. Assessment of first-cycle toxicity will be used to identify the recommended phase II dose for VAL-413. Toxicity will be evaluated and documented using NCI CTCAE guidelines. The recommended Phase II dose will be identified as the highest dose at which no more than 1 of 6 patients experiences a first cycle dose limiting toxicity (DLT).
Tracking Information
- NCT #
- NCT04337177
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Lars Wagner, M.D. Duke University Children's Hospital & Health Center
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