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New treatment option for CNS Malignancies
Official title A Phase 0/1 Study of cDNA for TP53, Checkpoint Inhibition and Radiation in Children With Recurrent, Progressive or Refractory CNS Malignancies.
ClinicalTrials.gov ID: NCT07017816
What this study is testing
What is SGT-53?
SGT-53 is an investigational medicine, being studied as a potential treatment for cns malignancies.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 3 to 21
You may be able to join if
- Tumor a. Patients must have a recurrent, progressive, or refractory CNS malignancy for which there are not known curative options. i...
- 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 must have recovered from the acute effects of prior therapy. Adverse events resulting from prior surgical intervention will not be an...
- Chemotherapy: Patients must have received their last dose of known chemotherapy at least two (2) weeks prior to receipt of SGT-53.
- Biologic therapy: Patients must have received their last dose of biological agent \>7 days prior to receipt of SGT-53.
You likely can't join if
- 1\. Low-grade-glioma, craniopharyngioma, and other non-malignant CNS tumors are excluded.
- 2\. Patients with diagnosis of diffuse midline gliomas (DMGs) are excluded. 3. Patients with any clinically significant unrelated systemic illness...
- 4\. Patients with pre-existing cardiac dysfunction defined as baseline EF of less than 35% 5. Patients with pre-existing pulmonary fibrosis...
- 6\. Patients who are receiving any other investigational drug therapy 7. Patients who in the opinion of the investigator cannot adhere to protocol...
- 9\. Patients who have received a live vaccine within 30 days of start of study treatment are not eligible.
- 10\. Patients with known HIV/AIDS or acute/chronic Hepatitis B or C are excluded.
See the full eligibility criteria
- Tumor a. Patients must have a recurrent, progressive, or refractory CNS malignancy for which there are not known curative options. i. Medulloblastoma, ATRT, High grade gliomas, pineoblastomas, embryonal tumors NOS, CNS...
- 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. b. Must have...
- 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.
- Biologic therapy: Patients must have received their last dose of biological agent \>7 days prior to receipt of SGT-53.
- Radiation therapy: Patients must be deemed to be a reasonable candidate for hypofractionated irradiation from a clinical standard of care perspective. i. At least 3 months from craniospinal radiation therapy, ii. Other...
- Absolute neutrophil count \>750/ul
- Platelets ≥75,000/ul
- Hemoglobin ≥8g/dL (may be supported with transfusion)
- Total bilirubin ≤1.5x ULN
- ALT/AST ≤3x ULN
- Serum albumin ≥2g/dL
- Normal cardiac function defined as ejection fraction within normal limits for age and gender
- a serum creatinine based on age/gender as below or a creatinine clearance or serum GFR ≥ 70ml/min/1.73m2: Serum Creatinine for age/sex Age Maximum Serum Creatinine (mg/dL) Male Female
- \<2 years 0.6 0.6
- \ 16 years 1.7 1.4 The threshold creatinine values in this table were adapted from the Schwartz formula for estimating GFR (Schwartz et al. J. Peds 106:.522, 1985) utilizing child length and stature data published by...
- 1\. Low-grade-glioma, craniopharyngioma, and other non-malignant CNS tumors are excluded.
- 2\. Patients with diagnosis of diffuse midline gliomas (DMGs) are excluded. 3. Patients with any clinically significant unrelated systemic illness (serious infection or significant cardiac, pulmonary, hepatic, or other...
- 4\. Patients with pre-existing cardiac dysfunction defined as baseline EF of less than 35% 5. Patients with pre-existing pulmonary fibrosis, interstitial lung disease, and clinically significant pulmonary lung disease.
- 6\. Patients who are receiving any other investigational drug therapy 7. Patients who in the opinion of the investigator cannot adhere to protocol requirements 8. Patients with history of autoimmune diseases that...
- 9\. Patients who have received a live vaccine within 30 days of start of study treatment are not eligible.
- 10\. Patients with known HIV/AIDS or acute/chronic Hepatitis B or C are excluded.
- 11\. Patients who are prohibited from receiving radiation therapy (reached maximum lifetime dose) are not eligible.
The study team makes the final eligibility decision.
Where it's taking place
- Washington D.C., District of Columbia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 3 years to 21 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Washington D.C., District of Columbia, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.