DaRT Seeds for Brain Cancer

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Alpha Tau Medical LTD.

Must not be taking: VEGF inhibitors

Disqualifiers: More than 3 relapses, Immunocompromised, Uncontrolled hypertension, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

Duration: 1 day

10 Participants Needed

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. ^{1 2 3 4 5}

Why 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. ^{1 2 4 5 6}

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

Measurable disease per RANO criteria

Estimated life expectancy more than 6 months

Adequate blood counts and blood chemistry levels at initial screening

Exclusion Criteria

I have a condition that makes me bleed easily.

Pregnancy or lactation

Prior allergic reaction to the study drugs

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

DaRT seeds are inserted into the tumor using a designated Alpha DaRT Applicator

1 day

1 visit (in-person)

Follow-up

Participants return for follow-up visits every 2 months to monitor safety and effectiveness

12 months

6 visits (in-person)

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

Trial Overview

The study is testing the safety and feasibility of a device called DaRT seeds that emit alpha radiation directly into the tumor in patients with recurrent glioblastoma.

How Is the Trial Designed?

Group I: Experimental: DaRT seeds Experimental Treatment 1 Intervention

DaRT sources are inserted into the tumor according to a pre determined plan. The delivery of the DaRT Sources into the tumor is done by using a designated Alpha DaRT Applicator .

Who Is Running the Clinical Trial?

Alpha Tau Medical LTD.

Lead Sponsor

Trials

28

Recruited

920+

Published Research Related to This Trial

In a study of 101 patients with malignant glioma, only 27% were eligible for adjuvant stereotactic radiosurgery, and these eligible patients had significantly longer median survival times (23.4 months) compared to ineligible patients (8.6 months).

The findings suggest a substantial selection bias in uncontrolled trials of stereotactic radiosurgery, indicating that a phase III randomized study may not be necessary as it is unlikely to show positive results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Measuring bias in uncontrolled brain tumor trials--to randomize or not to randomize? Irish, WD., Macdonald, DR., Cairncross, JG.[2019]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11937107/

Stereotactic implantation of diffusing alpha-emitters radiation ...

In a first-in-human clinical trial, Alpha DaRT reached a 78.6% (22/28) complete response rate in skin, head and neck cancers [24] and a second ...

2.

targetedonc.com

targetedonc.com/view/fda-approves-ide-application-for-alpha-dart-in-recurrent-glioblastoma

FDA Approves IDE Application for Alpha DaRT in ...

A first-in-human trial showed a 100% overall response rate, with a complete response rate exceeding 78%. Alpha DaRT has also shown efficacy in ...

3.

sciencedirect.com

sciencedirect.com/science/article/pii/S0360301622031881

Diffusing Alpha-Emitters Radiation Therapy Promotes a ...

DaRT promotes a “hot” tumor microenvironment and changes in immune suppression that lead to a potentiation of aPD-1 blockade induced effector T cell function.

4.

alphatau.com

alphatau.com/publications

Alpha DaRT | Publications

Alpha DaRT has proven safety and efficacy on all solid tumors tested (over 6000) and was published in over 16 articles in the most esteemed scientific ...

5.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06910306?spons=COVERAGE%5BFullMatch%5DEXPANSION%5BNone%5D(%22Alpha%20Tau%20Medical%20LTD.%22)&viewType=Table&rank=2

NCT06910306 | A Study to Assess the Feasibility and ...

Feasibility will be determined according to the rate of successful placement of Alpha DaRT sources into brain tumors.

6.

jrpr.org

jrpr.org/journal/view.php?number=1171

A Comprehensive Review of Diffusing Alpha-Emitters ...

DaRT emerges as a highly localized cancer treatment method with minimal side effects compared to traditional radiation therapy.