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Combination Therapy for Glioblastoma
Phase < 1
Waitlist Available
Led By Wenyin Shi, MD
Research Sponsored by Sidney Kimmel Cancer Center at Thomas Jefferson University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from enrollment up to 1 year
Awards & highlights
Summary
This trial is testing a new combination of treatments for glioblastoma.
Who is the study for?
This trial is for adults with newly diagnosed grade IV glioblastoma. Participants must have adequate blood counts, kidney and liver function, and be at least 21 days post-surgery or 14 days post-biopsy. Women who can bear children need a negative pregnancy test before joining.
What is being tested?
The study tests the combination of Temozolomide (chemotherapy), Radiation Therapy, and NovoTTF-200A Device (a device that disrupts cancer cell growth) to see if they work better together in treating glioblastoma.
What are the potential side effects?
Possible side effects include fatigue, skin irritation from the device, nausea from chemotherapy, and typical radiation therapy side effects like hair loss or headaches.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from enrollment up to 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from enrollment up to 1 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
NovoTTF-200A device discontinuation rate due to skin toxicity
Secondary study objectives
Event-free survival
Overall survival
Progression-free survival
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (temozolomide, radiation, NovoTTF-200A device)Experimental Treatment4 Interventions
Participants receive temozolomide PO QD starting day 1 to the end of radiation therapy and undergo 30 fractions of radiation therapy over 15-20 minutes each, 5 days a week (Monday-Friday) for 6 weeks. Beginning day 1 of radiation therapy, participants undergo tumor treatment fields therapy using NovoTTF-200A device over 18 hours or more daily in the absence of disease progression or unacceptable toxicity. Beginning 28 days after the last dose of radiation therapy, participants receive temozolomide PO QD on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tumor Treating Fields Therapy
2018
Completed Early Phase 1
~30
Temozolomide
FDA approved
Radiation Therapy
2017
Completed Phase 3
~7250
NovoTTF-200A Device
2018
Completed Early Phase 1
~30
Find a Location
Who is running the clinical trial?
Sidney Kimmel Cancer Center at Thomas Jefferson UniversityLead Sponsor
162 Previous Clinical Trials
10,881 Total Patients Enrolled
2 Trials studying Glioblastoma
142 Patients Enrolled for Glioblastoma
NovoCure Ltd.Industry Sponsor
58 Previous Clinical Trials
4,712 Total Patients Enrolled
28 Trials studying Glioblastoma
2,724 Patients Enrolled for Glioblastoma
Wenyin Shi, MDPrincipal InvestigatorSidney Kimmel Cancer Center at Thomas Jefferson University
2 Previous Clinical Trials
215 Total Patients Enrolled
1 Trials studying Glioblastoma
125 Patients Enrolled for Glioblastoma
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