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 range1 Year – 21 Years
SexALL
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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…