DaRT Seeds for Brain Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests DaRT seeds, a new approach for treating recurrent glioblastoma, an aggressive brain cancer. The seeds release radiation directly into the tumor to slow or stop its growth. Individuals with a confirmed diagnosis of recurrent glioblastoma, specific tumor characteristics, and prior radiation treatment might be suitable for this trial. Participants should not be eligible for surgery and must show tumor progression according to recent scans.
As an unphased trial, this study provides a unique opportunity to explore a novel treatment for recurrent glioblastoma.
Will I have to stop taking my current medications?
The trial protocol does not specify if you must stop taking your current medications, but it does mention that you cannot have recent or current therapy with certain drugs like VEF or VEGFR inhibitors. Additionally, there is a required washout period of 42 days for nitrosureas (a type of chemotherapy).
What prior data suggests that this device is safe for treating recurrent Glioblastoma?
Research has shown that DaRT seeds, which use alpha radiation, have been tested in people. In one study, they achieved a 78.6% success rate in treating skin, head, and neck cancers, meaning most patients experienced tumor shrinkage or disappearance.
Another review found that DaRT targets the tumor directly, affecting very little of the nearby healthy tissue. This can lead to fewer side effects compared to traditional radiation therapy. The treatment has been tested on over 6,000 solid tumors, indicating a good track record for safety and effectiveness.
In summary, existing research suggests that DaRT seeds are generally well-tolerated by patients. They offer a promising and focused way to treat tumors, with minimal side effects.12345Why are researchers excited about this trial?
Unlike the standard treatments for brain cancer, which typically involve surgery, radiation, and chemotherapy, DaRT seeds offer a unique approach by delivering targeted alpha radiation directly into the tumor. This method utilizes a special applicator to insert radioactive sources precisely where they're needed, potentially minimizing damage to surrounding healthy tissue. Researchers are excited about DaRT seeds because this localized delivery of alpha particles could enhance effectiveness and reduce side effects compared to traditional therapies.
What evidence suggests that the DaRT seeds device is effective for brain cancer?
Research has shown that DaRT seeds, which participants in this trial will receive, have successfully treated some types of cancer. In a previous study, this treatment completely eliminated cancer in over 78% of cases involving skin, head, and neck cancers. It also achieved a 100% overall response rate, meaning all patients experienced some level of improvement. The treatment alters the environment around the tumor and boosts the body's immune system to help fight the cancer. These results suggest that DaRT seeds might also be effective in treating recurrent Glioblastoma, a type of brain cancer.12456
Are You a Good Fit for This Trial?
This trial is for individuals with recurrent glioblastoma, a type of brain cancer. Specific eligibility criteria are not provided, but typically participants would need to meet certain health standards and have no conflicting conditions.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
DaRT seeds are inserted into the tumor using a designated Alpha DaRT Applicator
Follow-up
Participants return for follow-up visits every 2 months to monitor safety and effectiveness
Survival Follow-up
Survival follow-up conducted via phone calls every 2-3 months until new treatment, progression, or death
What Are the Treatments Tested in This Trial?
Interventions
- DaRT seeds
Find a Clinic Near You
Who Is Running the Clinical Trial?
Alpha Tau Medical LTD.
Lead Sponsor