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SGT-53 in Children With Recurrent or Progressive CNS Malignancies

NCT03554707 · Status: WITHDRAWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL

Last updated 2026-05-08

No results posted yet for this study

Summary

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

Conditions

  • Childhood CNS Tumor

Interventions

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

Sponsors & Collaborators

  • SynerGene Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Eugene Hwang, MD · Children's National Research Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Year
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-01
Primary Completion
2022-06-01
Completion
2022-06-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03554707 on ClinicalTrials.gov