SGT-53 in Children With Recurrent or Progressive CNS Malignancies (NCT03554707) | Clinical Trial Compass
WithdrawnEarly Phase 1
SGT-53 in Children With Recurrent or Progressive CNS Malignancies
Stopped: The grant intended to support this trial as ultimately not funded. This trial was not initiated,. No patients were enrolled.
United States0Started 2022-06-01
Plain-language summary
An early phase 1 for pediatric patients with recurrent or progressive CNS malignancies
Who can participate
Age range
1 Year – 21 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients must have a recurrent, progressive, or refractory CNS malignancy for which there are not known curative options. Low-grade glioma, craniopharyngioma, and other non-malignant CNS tumors are excluded.
* Tumor must be measureable, defined as a tumor that can be accurately measured in two perpendicular dimensions on MRI.
* Patients with metastatic disease are eligible but must have at least one target lesions which is measurable.
* Patients must have available archival (formalin-fixed paraffin embedded) or fresh tumor tissue for correlative studies.
* Patients must be \>1yrs and \<21 years of age.
* Must have recovered from all surgical interventions prior to the start of the Radiation and Chemotherapy Phases.
* Patients must have recovered from the acute effects of prior therapy.
* There is a maximum of 3 previous myelosuppressive therapy regimens. However, there is no maximum number of therapeutic courses.
* Patients must have received their last dose of known myelosuppressive therapy at least three (3) weeks prior to receipt of SGT-53.
* Patients must have received their last dose of biological agent \>7 days prior to receipt of SGT-53.
* Patients must be far enough from previous irradiation that in the opinion of a radiation oncologist using standard fractionation is deemed to be reasonable from a clinical standard of care perspective.
* Patients who are receiving dexamethasone or other corticosteroids must be on a stable or decreasing dose for…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.