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NovoTTF-200A for Glioblastoma

Phase 1
Waitlist Available
Led By Samuel Goldlust, MD
Research Sponsored by Hackensack Meridian Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Life expectancy of at least 3 months.
Sexually active participants must agree to the strict use of barrier contraception.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months
Awards & highlights

Study Summary

This trial is designed to study the safety and feasibility of using a medical device, NovoTTF-200A, with standard adjuvant treatment for newly diagnosed glioblastoma.

Eligible Conditions
  • Glioblastoma

Eligibility Criteria

Inclusion Criteria

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

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 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 Treatment-Emergent Adverse Events [Safety and Tolerability]
Secondary outcome measures
Overall survival time
Progression free survival at 6 months
Quality of life assessed using a European Organization for Research and Treatment of Cancer (EORTC) Brain Cancer questionnaire (BN20)
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: NovoTTF-200A + Temozolomide ChemoradiationExperimental Treatment3 Interventions
NovoTTF-200A, concomitant with radiotherapy and temozolomide, as front-line therapy for glioblastoma
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
NovoTTF-200A
2017
Completed Phase 1
~20
Temozolomide
FDA approved
3D conformal or intensity modulated radiation therapy (IMRT)
2017
Completed Phase 1
~20

Find a Location

Who is running the clinical trial?

Hackensack Meridian HealthLead Sponsor
131 Previous Clinical Trials
28,232 Total Patients Enrolled
NovoCure Ltd.Industry Sponsor
56 Previous Clinical Trials
4,621 Total Patients Enrolled
28 Trials studying Glioblastoma
2,723 Patients Enrolled for Glioblastoma
Samuel Goldlust, MDPrincipal InvestigatorHackensack Meridian Health
1 Previous Clinical Trials
125 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 maladies has NovoTTF-200A been established to alleviate?

"The NovoTTF-200A device is commonly employed to address issues related to nitrosourea therapy. Additionally, it has proven effective at treating certain advanced cases of mycosis fungoides, refractory neuroblastoma, and directives which are resistant to other treatments."

Answered by AI

Is this project presently enrolling new participants?

"This trial has stopped recruitment, having been initially posted on July 26th 2017 and last updated October 7th 2022. Currently, 442 studies are sourcing patients with glioblastoma while 206 trials seek volunteers for NovoTTF-200A treatment."

Answered by AI

Is this the inaugural investigation of its kind?

"Since its inception in 2002, NovoTTF-200A has been subject to numerous clinical trials. The initial trial was conducted by Schering-Plough and included 60 participants; following this study, the drug gained Phase 2 approval from regulatory bodies. Nowadays, there are 206 active investigations involving this medication scattered across 36 countries and 935 cities."

Answered by AI

Has NovoTTF-200A been previously investigated in any other research studies?

"Currently, 206 NovoTTF-200A studies are ongoing with 23 in Phase 3. The main hub of these trials is located in Seoul Songpa; however, there are 4751 sites that have launched investigations into this treatment option."

Answered by AI

How many individuals are receiving treatment through this trial?

"This clinical trial has reached its recruitment capacity, with the initial posting on July 26th 2017 and latest edit on October 7th 2022. Alternative studies are available for glioblastoma and NovoTTF-200A; 442 trials recruiting participants and 206 respectively."

Answered by AI

Are there any known adverse effects associated with NovoTTF-200A?

"Our research team at Power assigned a value of 1 to the safety profile of NovoTTF-200A due to its Phase 1 status, which indicates that there is limited documentation concerning efficacy and safety."

Answered by AI
Recent research and studies
~2 spots leftby Mar 2025