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Gene Therapy

SGT-53 Combination Therapy for Childhood Brain Cancer

Phase < 1
Waitlist Available
Led By Eugene Hwang, MD
Research Sponsored by SynerGene Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Last dose of known myelosuppressive therapy at least three weeks prior to receipt of SGT-53
Tumor must be measureable, defined as a tumor that can be accurately measured in two perpendicular dimensions on MRI
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 36 months
Awards & highlights

Study Summary

This trial is for children with cancer that has come back or is getting worse.

Who is the study for?
This trial is for children under 21 with recurrent or progressive brain tumors, who've had no more than three prior chemo treatments and have stable neurological deficits. They must not be pregnant, on a stable dose of steroids if used, and agree to birth control use. Those with low-grade gliomas or certain other conditions are excluded.Check my eligibility
What is being tested?
The study tests SGT-53 combined with chemotherapy drugs Irinotecan and Temozolomide, Bevacizumab (except in cases of significant clot or hemorrhage history), and Radiation therapy in pediatric patients to evaluate the safety and preliminary effectiveness against CNS malignancies.See study design
What are the potential side effects?
Potential side effects include reactions related to immune system suppression such as increased risk of infection, bleeding complications especially when using Bevacizumab unless excluded due to clotting history, organ function issues from chemotherapy agents, and general fatigue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I last received treatment that can lower my blood cell counts over three weeks ago.
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My tumor can be clearly measured on an MRI.
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My brain cancer is growing or returning and cannot be cured with known treatments.
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I am mostly active and can do things for myself.
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I am not pregnant or breastfeeding, and my pregnancy test was negative.
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My organs and bone marrow are functioning normally.
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I am between 1 and 21 years old.
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I have had up to 3 different treatments that can lower my blood cell counts.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~36 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 36 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of Adverse Events
Secondary outcome measures
Characterization of Phenotype of Patients
Duration of Response
Feasibility of Droplet PCR Assays to Monitor for Tumor Burden
+3 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: SGT-53 with radiation or drugsExperimental Treatment5 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Radiation
2003
Completed Phase 3
~1020
Temozolomide
2010
Completed Phase 3
~1930
SGT-53
2008
Completed Phase 1
~30
Bevacizumab
2013
Completed Phase 4
~5280
Irinotecan
2017
Completed Phase 4
~2680

Find a Location

Who is running the clinical trial?

SynerGene Therapeutics, Inc.Lead Sponsor
5 Previous Clinical Trials
85 Total Patients Enrolled
Eugene Hwang, MDPrincipal InvestigatorChildren's National Research Institute
4 Previous Clinical Trials
137 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the criteria for inclusion in this clinical trial?

"This research project is searching for 6 children between the ages of one and twenty-one with a CNS tumor. To be eligible, they must have at least one measureable metastatic lesion, their last dose of myelosuppressive therapy must have been administered three weeks prior to receiving SGT-53, there can only be up to three previous myelosuppressive therapies, available tissue samples from formalin-fixed paraffin embedded or fresh sources are necessary for correlative studies, all acute effects from past treatments need to have recovered before commencing chemotherapy and radiation phases of treatment, and any biological agent used must have had"

Answered by AI

How many participants are included in this research endeavor?

"At the present moment, this trial is not accepting participants. Initially posted on June 1st 2022 and most recently adjusted on February 7th 2022, it is wise to look into other clinical trials - 2445 related to CNS tumor in children and 739 associated with SGT-53 are actively seeking enrolment."

Answered by AI

Is there capacity for additional participants in this experiment?

"At the moment, this research endeavour is not seeking new participants. It was initiated on June 1st 2020 and last updated February 7th 2022. If you are searching for other medical trials, there are presently 2445 studies with CNS tumors related to childhood that require volunteers and another 739 trials actively recruiting individuals who have SGT-53."

Answered by AI

Is the age of eligibility for this clinical trial inclusive of those over 65 years?

"According to the trial's criteria for inclusion, no participant can be younger than 1 Year of age or older than 21 years old."

Answered by AI

Are there any other investigations into the efficacy of SGT-53?

"Presently, there are 739 ongoing studies related to SGT-53 with 150 trials in the final phase. The majority of these investigations are concentrated within Houston, Texas; however, an impressive 27455 different trial locations support research into this drug."

Answered by AI

In what clinical contexts is SGT-53 typically recommended?

"SGT-53 is usually prescribed to patients with soft tissue sarcoma. Additionally, the drug can be used in cases of recurrent platinum-sensitive epithelial ovarian cancer, malignant neoplasms, and refractory ewing sarcoma."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
SGT-53 in Children With Recurrent or Progressive CNS Malignancies
2022. "SGT-53 in Children With Recurrent or Progressive CNS Malignancies". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03554707.
~2 spots leftby Apr 2025
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