RRx-001 Given With Irinotecan and Temozolomide for Pediatric Patients With Recurrent or Progressive Malignant Solid and Central Nervous System Tumors — PIRATE  

Unspecified Childhood Solid Tumor, Protocol Specific Clinical Trial

Official title: A Phase 1 Trial of RRx-001 in Combination With Irinotecan and Temozolomide for Pediatric Patients With Recurrent or Progressive Malignant Solid and Central Nervous System Tumors

Status Active, not recruiting

Clinical Trial Summary

The PIRATE study tests the experimental drug RRx-001 in combination with 2 chemotherapy drugs that are commonly used in patients with cancer. RRx-001 has been used alone and with other anti-cancer medicines in adults. However, the investigators do not know what effects it will have in children and young adults.

Clinical Trial Description

The goals of the PIRATE study are:

• Determine if the adult dose of RRx-001 is safe when given together with 2 chemotherapy drugs called irinotecan and temozolomide in children and young adults with previously-treated cancerous tumors

• Determine the side effects of RRx-001 in children and young adults when given together with irinotecan and temozolomide

• Understand if the combination of RRx-001, irinotecan, and temozolomide is helpful for children and young adults with previously-treated cancerous tumors

• In patients with brain tumors, measure if RRx-001 causes changes in the tumor on Magnetic Resonance Imaging (MRI)

• Determine if RRx-001 causes changes in the immune system which may help the body naturally fight the tumor ;

Related Conditions & MeSH terms

• Brain Neoplasms
• Brain Tumor, Pediatric
• Brain Tumor, Recurrent
• Central Nervous System Neoplasms
• Neoplasms
• Nervous System Neoplasms
• Recurrence
• Unspecified Childhood Solid Tumor, Protocol Specific

• NCT number: NCT04525014
• Study type: Interventional
• Source: EpicentRx, Inc.
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: January 26, 2023
• Completion date: December 31, 2024