A Phase 0/1 Study of cDNA for TP53, Checkpoint Inhibition and Radiation in Children With Recurrent, Progressive or Refractory CNS Malignancies.

Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age3-21
SponsorChildren's National Research Institute

About this trial

This clinical trial is studying a drug called SGT-53 along with radiation and another drug called Nivolumab. It's for children with brain tumors that have come back, gotten worse, or didn't get better with earlier treatments. The main questions it aims to answer are:

What is the right dose of SGT-53 that children can safely receive when it is used with radiation and Nivolumab? This dose will be used in the second phase of the trial.

What side effects are there of SGT-53 when it is used with radiation and Nivolumab?

How does SGT-53 move through the body when given with radiation and Nivolumab?

How much of the SGT-53 drug is found in the tumor tissue? This will be tested in a small group of patients?

Participants will:

For the first treatment cycle:

Get SGT-53 twice per week Get Nivolumab every 2 weeks Receive radiation therapy during week 2

For Cycles 2-6:

Get SGT-53 once per week during even cycles and twice per week during odd cycles Get Nivolumab every 2 weeks For Cycles 7+ Get both SGT-53 and Nivolumab every 2 weeks In the phase 0 part of the study, 4 participants will have genetic testing performed on their tumor tissue after receiving SGT-53. These samples will be compared to another sample taken from the skin.

Eligibility criteria

Qualifiers

Tumor

Patient Characteristics a. The first 3 patients will be >7 years old to <22 years old i. Following initial successful treatment of the first 3 patients: Patients must be ≥3yrs and <22 years of age.

Patients must have recovered from the acute effects of prior therapy. Adverse events resulting from prior surgical intervention will not be an ineligibility criterion.

Chemotherapy: Patients must have received their last dose of known chemotherapy at least two (2) weeks prior to receipt of SGT-53.

Disqualifiers

1. Low-grade-glioma, craniopharyngioma, and other non-malignant CNS tumors are excluded.

Trial design

Treatments tested in this trial

  • SGT-53
  • hypofractionated radiotherapy with immunotherapy
  • Nivolumab

Treatment groups

18 Participants
are divided into 1 treatment group