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

PHASE1TerminatedINTERVENTIONAL
Enrollment

2

Participants

Timeline

Start Date

January 26, 2023

Primary Completion Date

July 29, 2024

Study Completion Date

July 29, 2024

Conditions
Brain Tumor, RecurrentBrain Tumor, PediatricCentral Nervous System NeoplasmsUnspecified Childhood Solid Tumor, Protocol Specific
Interventions
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

Trial Locations (1)

77030

Texas Children's Cancer Center, Houston

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Texas Children's Cancer Center

OTHER

lead

EpicentRx, Inc.

INDUSTRY