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Tyrosine Kinase Inhibitor
Regimen C for Pediatric Brain Tumor (SEED Trial)
N/A
Waitlist Available
Led By Sarah ES Leary, MD
Research Sponsored by Seattle Children's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
SEED Trial Summary
This research study is a Feasibility clinical trial. In this trial, researchers are trying to figure out whether a medication can be chosen based on rapid testing done on tumor tissue. Information from a feasibility or pilot trial will hopefully help researchers plan larger trials in the future to determine the effect of this therapy.
Eligible Conditions
- Pediatric Brain Tumor
SEED Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Feasibility
Secondary outcome measures
Efficacy
Survival
Toxicity
SEED Trial Design
4Treatment groups
Experimental Treatment
Group I: Regimen DExperimental Treatment4 Interventions
Depending on tumor biology testing, subjects assigned to Regimen D will receive:
Temozolomide 150 mg/m2/dose daily PO on days 1-5, Etoposide 50 mg/m2/dose daily PO on days 1-12, and Dasatinib 60 mg/m2/dose BID PO on days 1-28. Cycles will be repeated every 28 days for up to 12 cycles.
Group II: Regimen CExperimental Treatment4 Interventions
Depending on tumor biology testing, subjects assigned to Regimen C will receive:
Temozolomide 150 mg/m2/dose daily PO on days 1-5, Etoposide 50 mg/m2/dose daily PO on days 1-12, and Erlotinib 85 mg/m2/dose daily PO on days 1-28. Cycles will be repeated every 28 days for up to 12 cycles.
Group III: Regimen BExperimental Treatment4 Interventions
Depending on tumor biology testing, subjects assigned to Regimen B will receive:
Temozolomide 150 mg/m2/dose daily PO on days 1-5, Etoposide 50 mg/m2/dose daily PO on days 1-12, and Everolimus 3 mg/m2/dose daily PO on days 1-28. Cycles will be repeated every 28 days for up to 12 cycles.
Group IV: Regimen AExperimental Treatment4 Interventions
Depending on tumor biology testing, subjects assigned to Regimen A will receive:
Temozolomide 150 mg/m2/dose daily PO on days 1-5, Etoposide 50 mg/m2/dose daily PO on days 1-12, and Sorafenib 150 mg/m2/dose BID PO on days 1-28. Cycles will be repeated every 28 days for up to 12 cycles.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sorafenib
FDA approved
Everolimus
FDA approved
Etoposide
FDA approved
Dasatinib
FDA approved
Erlotinib
FDA approved
Temozolomide
FDA approved
Find a Location
Who is running the clinical trial?
Cures Within ReachOTHER
19 Previous Clinical Trials
1,723 Total Patients Enrolled
Seattle Children's HospitalLead Sponsor
301 Previous Clinical Trials
5,216,957 Total Patients Enrolled
Sarah ES Leary, MDPrincipal InvestigatorSeattle Children's
Frequently Asked Questions
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