Nativis Voyager for Glioblastoma
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new therapy, the Nativis Voyager RFE Therapy, to determine its safety and effectiveness for individuals whose brain cancer, glioblastoma multiforme (GBM), has returned after standard treatments failed or were not tolerated. Participants will receive the Voyager therapy with lomustine and possibly bevacizumab to assess safety and effectiveness. Suitable participants must have a confirmed GBM diagnosis, have not responded to or cannot tolerate standard treatments, and have a tumor visible on an MRI scan. As an unphased trial, this study provides a unique opportunity to explore innovative treatment options for recurrent GBM.
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 prior data suggests that the Nativis Voyager RFE Therapy is safe?
Research has shown that the Nativis Voyager RFE Therapy is generally safe for people with recurring glioblastoma multiforme (GBM), a type of brain cancer. Studies have found that unwanted effects related to the device are rare. In one study involving 75 patients using the Voyager system, most did not experience significant issues with the device.
Some patients reported unwanted effects, but these were uncommon. Serious unwanted effects occurred even less frequently. In one group, 86% of patients reported at least one unwanted effect, but only 35% experienced a serious one.
Overall, evidence suggests that the Voyager system is well-tolerated. However, as with any treatment, individual experiences can differ. Discuss potential risks and benefits with a healthcare provider before joining a clinical trial.12345Why are researchers excited about this trial?
Unlike the standard treatments for recurrent glioblastoma multiforme, which usually involve surgery, radiation, and chemotherapy, the Nativis Voyager RFE Therapy offers a completely different approach. This therapy uses a unique radiofrequency energy (RFE) technology to target the tumor, potentially disrupting cancer cell growth without the invasive side effects associated with traditional methods. Researchers are excited about this treatment because it represents a non-invasive option that could provide a new avenue of hope for patients who have limited options after conventional treatments fail.
What evidence suggests that the Nativis Voyager RFE Therapy might be an effective treatment for GBM?
Research shows that the Nativis Voyager RFE Therapy, which participants in this trial will receive, might help slow the growth of glioblastoma, a fast-growing brain tumor. Studies in mice found that this therapy can delay tumor growth. Early human studies indicate that the therapy is safe and might be effective for treating recurrent glioblastoma. In some patients, the therapy stopped the tumor from growing for an average of 17 weeks. The therapy uses special waves to target and attack cancer cells.16789
Who Is on the Research Team?
Donna Morgan Murray, PhD
Principal Investigator
Nativis, Inc.
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
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
Long-term follow-up
Participants are monitored for progression-free survival and overall survival
What Are the Treatments Tested in This Trial?
Interventions
- Nativis Voyager RFE Therapy
Find a Clinic Near You
Who Is Running the Clinical Trial?
Nativis, Inc.
Lead Sponsor