37 Participants Needed

A Feasibility Study of the Nativis Voyager® System in Patients With Recurrent Glioblastoma Multiforme (GBM)

Recruiting at 12 trial locations
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, you cannot participate if you are currently being treated with other investigational agents or have received other investigational therapy within the last 28 days.

What is the purpose of this trial?

This trial will test a new treatment called Nativis Voyager therapy in patients with recurring brain cancer who haven't responded to or can't tolerate standard treatments. The treatment uses special waves to attack cancer cells, combined with drugs that stop cancer cells from multiplying and prevent tumors from getting nutrients. Up to 32 patients will be treated to see if this approach is safe and useful. The Nativis Voyager® device has been previously evaluated in patients with recurrent glioblastoma, showing promising results with no significant side effects reported.

Research Team

DM

Donna Morgan Murray, PhD

Principal Investigator

Nativis, Inc.

Eligibility Criteria

Inclusion Criteria

Subject has histologically confirmed diagnosis of GBM.
Subject has failed or intolerant to radiotherapy.
Subjects has failed or intolerant to temozolomide therapy.
See 3 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Nativis Voyager therapy with lomustine, with or without bevacizumab, until tumor progression

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 month

Long-term follow-up

Participants are monitored for progression-free survival and overall survival

18 months

Treatment Details

Interventions

  • Nativis Voyager RFE Therapy
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Nativis Voyager RFE TherapyExperimental Treatment1 Intervention
Subjects will be treated with Nativis Voyager therapy until tumor progression.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Nativis, Inc.

Lead Sponsor

Trials
3
Recruited
90+
Unbiased ResultsWe believe in providing patients with all the options.
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