Histotripsy for Kidney Cancer

(#HOPE4KIDNEY Trial)

Recruiting at 14 trial locations

Overseen By Zoe Secord

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: HistoSonics, Inc.

Must not be taking: Aspirin, NSAIDS, Anticoagulants

Disqualifiers: Pregnancy, Active cancers, Dialysis, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 195

Duration: 1 day

68 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this trial is to evaluate the effectiveness and safety of the HistoSonics Edison System for the destruction of kidney tissue by treating primary solid renal tumors.

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

The trial protocol does not specify if you need to stop taking your current medications, but you must not take Aspirin or NSAIDs within 7 days before the procedure. It's best to discuss your specific medications with the trial team.

How is the HistoSonics Edison System treatment different from other kidney cancer treatments?

The HistoSonics Edison System is unique because it uses sound waves to non-invasively destroy kidney cancer cells, unlike traditional treatments that often involve surgery, drugs, or radiation. This method, known as histotripsy, targets and breaks down cancerous tissue without the need for incisions or chemicals. ^{1 2 3 4 5}

Eligibility Criteria

This trial is for adults over 22 with a single, non-metastatic kidney tumor no larger than 3cm, confirmed by CT or MRI. Participants must be able to undergo general anesthesia and have certain blood count levels within normal ranges. They should not have had previous treatments on the tumor, be pregnant, or have specific genetic predispositions to kidney cancer.

Inclusion Criteria

I can take care of myself and am up and about more than half of my waking hours.

My tumor is 3cm or smaller in size.

My tumor can be seen clearly with ultrasound for treatment.

Exclusion Criteria

My treatment won't fully remove the cancer with safe margins.

My tumor was treated with targeted local therapy like radiation.

The doctors cannot clearly see the tumor with ultrasound, MRI, or CT scans.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a single histotripsy session using the HistoSonics Edison System for the destruction of kidney tissue

1 day

1 visit (in-person)

Primary Analysis

Data through 90 days for all enrolled subjects will be summarized for Regulatory Submission to the FDA

90 days

Evaluations at 14-day, 30-day, and 90-day time points

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years

Evaluations at 180-day and annual time points

Treatment Details

Interventions

• HistoSonics Edison System

Trial Overview The HistoSonics Edison System is being tested for its ability to safely destroy primary solid renal tumors using histotripsy—a non-invasive technique that uses ultrasound energy.

Participant Groups

Group I: HistoSonics Edison System Experimental Treatment 1 Intervention

HistoSonics Edison System is already approved in United States for the following indications:

Approved in United States as Edison System for:

• Liver tumors

Who Is Running the Clinical Trial?

HistoSonics, Inc.

Lead Sponsor

Trials

9

Recruited

5,200+

Findings from Research

An integrated therapy combining Vinblastine and alfa-2A-IFN was tested on 12 patients with metastatic renal carcinoma to reduce metastasis that couldn't be surgically removed and to limit micrometastatic spread.

The study suggests that this combined treatment may play a beneficial role following surgery, although further conclusions should be drawn cautiously.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Adjuvant therapy with vinblastine and interferon in metastatic renal carcinoma]. Cocimano, V., Marino, G., Brigato, R., et al.[2018]

Combining anti-CD3 monoclonal antibodies with IL-2 significantly improves treatment outcomes in a murine model of renal cell cancer, leading to fewer pulmonary metastases and longer survival compared to either treatment alone.

This combination therapy enhances the expression of key molecules involved in the immune response, such as perforin and granzyme B, suggesting a stronger cytotoxic attack against tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immunostimulatory therapy with anti-CD3 monoclonal antibodies and recombinant interleukin-2: heightened in vivo expression of mRNA encoding cytotoxic attack molecules and immunoregulatory cytokines and regression of murine renal cell carcinoma. Asano, T., Khanna, A., Lagman, M., et al.[2019]

Immunotherapy using tumor-infiltrating lymphocytes (TIL) shows promise as a new treatment for kidney cancer metastases, which are difficult to treat with traditional methods like surgery and chemotherapy.

In early clinical trials, activated lymphocytes, cultivated with Interleukin 2 to enhance their cancer-fighting abilities, have demonstrated encouraging results, indicating a potential breakthrough in cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[A new therapeutic concept in the treatment of metastatic cancers of the kidney: the TIL (tumor infiltrating lymphocytes)]. Peyret, C.[2006]

Checkpoint inhibitors (CPI) have transformed the first-line treatment for metastatic renal cell carcinoma, showing effectiveness and safety when combined with tyrosine kinase inhibitors (TKI).

Currently, up to five different combination treatments are available based on individual patient risk profiles, emphasizing the need for personalized treatment plans and interdisciplinary discussions for complex cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[First-line treatment of metastatic renal cell carcinoma]. Bruchbacher, A., Netsch, C., Gross, AJ.[2023]

Allogeneic anti-CD3 antibody induced activated killer (CD3AK) cells demonstrated a significant inhibitory effect on the growth of human renal cell cancer (RCC) in SCID mice, leading to reduced tumor weight and slower tumor growth compared to control groups.

The study showed that CD3AK cells not only exerted a lethal effect on the OS-RC-2 renal cancer cell line but also enhanced the immune response in the mice, indicating their potential as a therapeutic option for RCC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of allogeneic CD3AK cells on transplanted human renal cell cancer in mice with severe combined immune deficiency. Ge, L., Shan, Z., Han, Q., et al.[2017]

References

1. Italy pubmed.ncbi.nlm.nih.gov

[Adjuvant therapy with vinblastine and interferon in metastatic renal carcinoma]. [2018]

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

Immunostimulatory therapy with anti-CD3 monoclonal antibodies and recombinant interleukin-2: heightened in vivo expression of mRNA encoding cytotoxic attack molecules and immunoregulatory cytokines and regression of murine renal cell carcinoma. [2019]

3. France pubmed.ncbi.nlm.nih.gov

[A new therapeutic concept in the treatment of metastatic cancers of the kidney: the TIL (tumor infiltrating lymphocytes)]. [2006]

4. Germany pubmed.ncbi.nlm.nih.gov

[First-line treatment of metastatic renal cell carcinoma]. [2023]

5. Cyprus pubmed.ncbi.nlm.nih.gov

Effectiveness of allogeneic CD3AK cells on transplanted human renal cell cancer in mice with severe combined immune deficiency. [2017]