NCT03554707

SGT-53 in Children With Recurrent or Progressive CNS Malignancies

A Pilot Study of SGT-53 in Conjunction With Irradiation and Chemotherapy in Children With Recurrent or Progressive CNS Malignancies

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 6 (estimated)
• Sponsor: SynerGene Therapeutics, Inc. · Industry
• Sex: All
• Age: 1 Year – 21 Years
• Healthy volunteers: Not accepted

Summary

An early phase 1 for pediatric patients with recurrent or progressive CNS malignancies

Detailed description

This clinical trial is a early phase 1, open label, single center, single arm study of the combination of intravenously administered SGT-53 and irradiation and/or chemotherapy in pediatric patients with recurrent or progressive CNS malignancies. The objective of the study is to establish the safety and feasibility of administration of SGT-53 in conjunction with conventional radiotherapy and/or chemotherapy in children with recurrent or refractory CNS malignancies.

Conditions

• Childhood CNS Tumor

Interventions

Type	Name	Description
GENETIC	SGT-53	2.1 mg DNA/m2 or 2.8 mg DNA/m2 twice weekly
RADIATION	Radiation	Standard radiation plan
DRUG	Irinotecan	50mg/m2/dose IV daily for five days in a 4-week cycle
DRUG	Temozolomide	100mg/m2 PO daily for five days in a 4-week cycle
DRUG	Bevacizumab	10mg/kg IV every two weeks in a 4-week cycle

Timeline

• Start date: 2022-06-01
• Primary completion: 2023-12-01
• Completion: 2024-12-01
• First posted: 2018-06-13
• Last updated: 2022-02-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study