NCT04525014

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

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: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: EpicentRx, Inc. · Industry
• Sex: All
• Age: 1 Year – 21 Years
• Healthy volunteers: Not accepted

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.

Detailed 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

Conditions

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

Interventions

Type	Name	Description
DRUG	RRx-001	RRx-001 will be administered every 3 weeks via intravenous infusion at three dose levels: 0.5 mg/m2 (Max 1 mg), 1 mg/m2 (Max 2 mg), and 2 mg/m2 (Max 4 mg).
DRUG	Temozolomide	100 mg/m2 (children ≥0.5 m2) or 3 mg/kg (children \<0.5 m2) daily for 5 days beginning on day 1 of each cycle
DRUG	Irinotecan	90 mg/m2 taken orally daily for 5 days administered 1 hour after temozolomide

Timeline

• Start date: 2023-01-26
• Primary completion: 2024-07-29
• Completion: 2024-07-29
• First posted: 2020-08-24
• Last updated: 2024-10-31

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study