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Device

TTFields + SRS + Temozolomide for Glioblastoma

Phase 1

Waitlist Available

Led By Scott G Soltys

Research Sponsored by Stanford University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Platelet count ≥ 100 × 109/L without blood transfusions for 7 days preceding the lab assessment

Age ≥ 18 years

Must not have

Pharmacotherapy for tuberculosis or HIV as these medications are known to interact with temozolomide

Subjects with known cirrhosis diagnosed with Child Pugh Class A or higher liver disease.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new combination therapy for newly diagnosed glioblastoma (GBM). The safety and efficacy of the combination therapy of TTFields + SRS+ Temozolomide (TMZ) will be determined.

Who is the study for?

Adults diagnosed with newly confirmed glioblastoma, able to undergo MRI, and have good organ function. Participants must not be pregnant or nursing, should not have other severe illnesses or skin conditions that could interfere with treatment, and cannot be on certain medications like those for tuberculosis or HIV.

What is being tested?

The trial is testing a combination therapy for brain cancer (glioblastoma) using Tumor Treating Fields (TTFields), Stereotactic radiosurgery (SRS), and the chemotherapy drug Temozolomide to evaluate safety and effectiveness.

What are the potential side effects?

Possible side effects include skin irritation from TTFields device adhesives, fatigue from radiotherapy, nausea from chemotherapy, potential liver enzyme changes due to medication interactions, and increased risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My platelet count is healthy without needing blood transfusions in the past week.

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I am 18 years old or older.

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I have been newly diagnosed with glioblastoma or its molecular equivalent.

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My white blood cell count is healthy without needing medication for the past week.

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I can care for myself but may need occasional help.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not on medication for tuberculosis or HIV.

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I have cirrhosis but my liver still works relatively well.

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I am not currently on any cancer treatments like chemotherapy or targeted therapy.

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I have had chemotherapy or radiotherapy for brain cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Dose-limiting Toxicity (DLTs)

Secondary study objectives

Acute dose limiting toxicity

Overall Survival (OS)

Progression-free Survival (PFS) at 6 Months

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Novo-TTFExperimental Treatment4 Interventions

Day 1: Subjects will wear the Optune (TTFields device) for ≥ 18 hours/day. They will take off the device when receiving stereotactic radiosurgery and brain MRI scans. Days 1 to 8: Subjects will take oral temozolomide 75 mg/m2/day Days 2 to 8: Subjects will receive stereotactic radiosurgery (total of 35 Gy) divided equally over 5 days • After the interventional treatment, subjects will receive standard of care adjuvant chemotherapy and routine surveillance brain MRI scans.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Optune

2016

Completed Phase 1

~90

Gadolinium

2006

Completed Phase 4

~620