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

Trial Summary

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 data supports the effectiveness of the DaRT seeds treatment for brain cancer?

The research does not provide direct evidence for the effectiveness of DaRT seeds in treating brain cancer, but it highlights the importance of increased dose intensity in improving response rates and survival in solid tumors, which may suggest potential benefits of intensive treatments like DaRT seeds. ^{1 2 3 4 5}

How does the DaRT seeds treatment differ from other treatments for brain cancer?

DaRT seeds treatment is unique because it involves the direct implantation of radioactive seeds into the brain tumor, allowing for targeted radiation therapy that minimizes damage to surrounding healthy tissue. This method is different from traditional treatments that often struggle to deliver effective doses due to the protective blood-brain barrier. ^{6 7 8 9 10}

What is the purpose of this trial?

A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device for the treatment of recurrent Glioblastoma

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Feasibility of sequential high-dose chemotherapy and peripheral blood stem cell support for pediatric central nervous system malignancies. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Inclusion of patients with brain metastases in phase I trials: an unmet need. [2018]

3. Germany pubmed.ncbi.nlm.nih.gov

Prospective randomized cooperative medulloblastoma trial (MED 84) of the International Society of Paediatric Oncology (SIOP) and of the (German) Society of Paediatric Oncology (GPO). [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Clinical trial design in brain metastasis: approaches for a unique patient population. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Measuring bias in uncontrolled brain tumor trials--to randomize or not to randomize? [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Stereotactic interstitial irradiation for the treatment of brain tumors. [2016]

7. United States pubmed.ncbi.nlm.nih.gov

An improved rat brain-tumor model. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Drug delivery to brain tumors. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Stereotactic brachytherapy of low-grade cerebral glioma after tumor resection. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

A case of recurrent subependymoma with subependymal seeding: case report. [2019]