SGT-53 in Children With Recurrent or Progressive CNS Malignancies

Conditions

• Childhood CNS Tumor

Eligibility Criteria

Sex

ALL

Age

1 Year - 21 Years

Healthy Volunteers

Not accepted

Interventions

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

Study Details

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

Key Dates

Start date

Jun 1, 2022

Status verified

May 2026

Primary completion

Jun 1, 2022

Completion

Jun 1, 2022

Study Design

Enrollment

0 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: SGT-53 with radiation or drugs
  Radiation phase: SGT-53 will be given at 2.1 mg DNA/m2 twice weekly for the first week of radiation therapy, and then increase to 2.8 mg DNA/m2 twice weekly. Radiation therapy will be administered as per clinical care, with a target of fifteen (15) fractions, but patients with other clinically-determined radiation plans will be allowed. Chemotherapy phase: SGT-53 will be administered at the highest tolerated dose given during radiation phase. Irinotecan will be given at a dose of 50mg/m2/dose IV daily for five days in a 4-week cycle. Temozolomide will be given at a dose of 100mg/m2 PO daily for five days in a 4-week cycle and bevacizumab will be given at a dose of 10mg/kg IV every two weeks in a 4-week cycle.

Primary Outcome Measure

Incidence of Adverse Events [ Time Frame: up to 13 months ]

Locations (1)

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