Interstitial Radiation Therapy for Kidney Cancer

Recruiting in Palo Alto (17 mi)

Overseen by Albert Chang, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Recruiting

Sponsor: Jonsson Comprehensive Cancer Center

Disqualifiers: Non-renal malignancy, Uncontrolled illness, others

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial studies the effects of a treatment that places a small radiation source directly inside or near large kidney cancer masses in patients who cannot have surgery. The treatment aims to shrink the tumor and prevent it from spreading. This approach has been shown to provide high tumor control rates in various types of cancer.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, since the trial excludes those with prior systemic treatment for kidney cancer, you may need to discuss your current medications with the trial team.

What data supports the effectiveness of the treatment Interstitial Radiation Therapy for Kidney Cancer?

Research shows that high-dose-rate interstitial brachytherapy (a type of internal radiation) has been effective in controlling tumors in various cancers, including metastatic renal cell carcinoma. Additionally, intraoperative radiotherapy (a similar approach) has shown high local tumor control in kidney cancer without increasing side effects. ^{1 2 3 4 5}

Is interstitial radiation therapy generally safe for humans?

Interstitial radiation therapy, also known as brachytherapy, has been studied for various conditions and is generally considered safe. Studies have shown it can be used effectively with manageable safety profiles, though there have been reports of accidents, which are being addressed with safety recommendations. ^{3 6 7 8 9}

How does interstitial radiation therapy differ from other treatments for kidney cancer?

Interstitial radiation therapy, also known as brachytherapy, is unique because it involves placing radioactive material directly inside or near the tumor, allowing for a high dose of radiation to target the cancer while minimizing exposure to surrounding healthy tissue. This method is particularly beneficial for treating localized tumors and can be combined with other therapies to improve treatment success rates. ^{3 5 10 11 12}

Research Team

Albert Chang, MD

Principal Investigator

UCLA / Jonsson Comprehensive Cancer Center

Eligibility Criteria

This trial is for adults with kidney cancer that's too large or unsuitable for surgery or ablation. They must not be candidates for curative surgery, have a tumor size of 4-10 cm without evidence of advanced disease, and have normal liver function tests. Women must test negative for pregnancy, and all participants need good blood counts and kidney function.

Inclusion Criteria

Your total bilirubin level is within the normal range.

I can do most of my daily activities without help.

My kidney cancer was confirmed through a biopsy.

Exclusion Criteria

I need urgent treatment for my kidney cancer due to bleeding, pain, or related symptoms.

I do not have any uncontrolled illnesses like infections or heart problems.

I have had surgery or radiation therapy at the site where I will have an operation.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients undergo interstitial brachytherapy for 1-2 fractions in the absence of disease progression or unacceptable toxicity. Patients who undergo 2 fractions may receive both fractions in the same day or on 2 separate days over 2 weeks.

2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 years

Every 3 months

Treatment Details

Interventions

• Interstitial Radiation Therapy (Brachytherapy)

Trial Overview The study is testing interstitial brachytherapy—a type of internal radiation therapy—on patients with large kidney tumors that can't be removed surgically. The goal is to see if this treatment can limit tumor growth and potentially shrink the cancer enough to lower the risk of it spreading.

Participant Groups

Group I: Treatment (interstitial brachytherapy) Experimental Treatment 1 Intervention

Patients undergo interstitial brachytherapy for 1-2 fractions in the absence of disease progression or unacceptable toxicity. Patients who undergo 2 fractions may receive both fractions in the same day or on 2 separate days over 2 weeks.

Interstitial Radiation Therapy is already approved in Canada for the following indications:

Approved in Canada as Brachytherapy for:

• Prostate cancer
• Breast cancer
• Cervical cancer
• Esophageal cancer
• Head and neck cancers
• Lung cancer
• Rectal cancer
• Soft tissue sarcomas
• Vaginal cancer
• Uterine (endometrial) cancer

Who Is Running the Clinical Trial?

Jonsson Comprehensive Cancer Center

Lead Sponsor

Trials

373

Recruited

35,200+

Dr. Aparna Bhaduri

Jonsson Comprehensive Cancer Center

Chief Medical Officer since 2024

MD

Dr. Michael A. Teitell

Jonsson Comprehensive Cancer Center

Chief Executive Officer since 2024

MD, PhD

Findings from Research

Out of 160 patients with renal cell carcinoma (RCC), 100 were treated with interventional radiology (IVR) techniques, primarily therapeutic arterial embolization or intraarterial infusion of anticancer drugs, during the late 1970s to late 1980s.

The study indicates that while IVR was used frequently in the early years, more recent treatments have shifted towards nephrectomies, and overall, IVR has shown greater effectiveness in treating hepatocellular carcinoma compared to RCC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical evaluation of interventional radiology for renal cell carcinoma in 100 patients. Minakuchi, K., Takada, K., Nishio, H., et al.[2016]

In a study of 17 patients with locally recurrent renal cell carcinoma, the combination of intraoperative electron radiation therapy (IOERT) and external beam radiation therapy (EBRT) achieved a high local control rate of 91% over two years, despite many patients having unfavorable surgical outcomes.

The treatment resulted in a 73% overall survival rate, but progression-free survival was limited due to a high rate of distant failures, highlighting the need for more aggressive systemic treatments, especially for patients with higher tumor grades and shorter intervals between surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intraoperative electron radiation therapy (IOERT) in patients with locally recurrent renal cell carcinoma. Habl, G., Uhl, M., Hensley, F., et al.[2021]

Intraoperative radiotherapy (IORT) combined with nephrectomy or rescue surgery in 11 patients with advanced renal carcinoma showed a high local tumor control rate of 82% at an average follow-up of 8 months, indicating its potential effectiveness in treating difficult cases.

No toxic effects or complications related to IORT were observed, suggesting that this treatment approach is safe for patients undergoing surgery for renal tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Intraoperative radiotherapy in locally advanced carcinoma of the kidney: initial experience]. Santos, M., Ucar, A., Ramos, H., et al.[2006]

In a pilot trial involving 16 patients with renal masses, CT-guided high-dose-rate brachytherapy (HDR-BT) demonstrated a high local control rate of 95% for tumors, indicating its effectiveness as a local ablative treatment.

The treatment was found to be safe, with only one patient requiring permanent hemodialysis and no significant worsening of renal function or major side effects observed in the other patients during a median follow-up of 22.5 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective evaluation of CT-guided HDR brachytherapy as a local ablative treatment for renal masses: a single-arm pilot trial. Damm, R., Streitparth, T., Hass, P., et al.[2020]

Iodine-125 prostate seed brachytherapy shows high rates of biochemical control for prostate cancer in renal transplant recipients, with all four patients in the study remaining free of PSA progression after an average follow-up of 44 months.

The treatment demonstrated minimal toxicity, as there were no peri-operative complications and all patients maintained normal kidney function, suggesting it is a safe alternative to traditional surgery and radiotherapy for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Iodine-125 prostate seed brachytherapy in renal transplant recipients: an analysis of oncological outcomes and toxicity profile. Beydoun, N., Bucci, J., Malouf, D.[2021]

High-dose-rate interstitial brachytherapy (iBT) for liver tumors shows a low major complication rate of less than 5%, with only 1.5% experiencing major bleeding, particularly in patients with advanced liver cirrhosis.

The treatment is effective, with a median overall survival of 20.1 months and an 89% local recurrence-free rate after 12 months, indicating its potential as a safe and effective option for patients with liver tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radioablation of liver malignancies with interstitial high-dose-rate brachytherapy : Complications and risk factors. Mohnike, K., Wolf, S., Damm, R., et al.[2022]

The ICRP Committee 3 is finalizing recommendations to prevent accidents in high-dose-rate brachytherapy, highlighting over 500 reported incidents and providing strategies to reduce their frequency and severity.

For prostate cancer brachytherapy using permanently implanted sources, while no severe accidents have been reported, the committee addresses radiation safety concerns related to patient dose, migrating seeds, and cremation, offering specific recommendations to mitigate these issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The recommendations of the International Commission on Radiological Protection (ICRP) for high-dose-rate brachytherapy and for permanent prostatic implants]. Cosset, JM., Pinillos-Ashton, L., Mettler, F.[2013]

Patients with advanced stage renal cell carcinoma treated with 125I interstitial infarct implants showed significantly improved survival rates, with 50% surviving at 2 years and 37% at 5 years.

The treatment, which involves transcatheter embolization, not only helps manage nonresectable tumors but may also enhance the host's immune response, making it a recommended option for patients who cannot undergo surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcatheter embolization of renal tumors with I-125 particles. Lang, EK.[2004]

In a study of 85 patients with metastatic renal cell carcinoma, the 2-year survival rate was 33% and the 5-year survival rate was 32%, with the best outcomes seen in patients with isolated skeletal metastases (69% at 2 years and 60% at 5 years).

The use of radioactive interstitial implants, particularly with iodine-125, not only reduced tumor burden but may also stimulate the immune response, leading to remission, although patients with CNS and other parenchymal metastases had poorer outcomes due to treatment limitations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of primary and metastatic renal cell carcinoma by transcatheter embolization with iodine 125. Lang, EK., Sullivan, J.[2019]

Interstitial brachytherapy is a modern and effective radiotherapy method that allows for high dose rate (HDR) treatment directly into tumor regions, improving success rates for localized tumors.

This technique is commonly used for various cancers, including breast, head and neck, and prostate tumors, and is enhanced by multidisciplinary management to improve patient outcomes and quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The role of interstitial brachytherapy in multimodality management of solid tumors]. Soumarová, R., Homola, L., Perková, H., et al.[2016]

References

1. Japan pubmed.ncbi.nlm.nih.gov

Clinical evaluation of interventional radiology for renal cell carcinoma in 100 patients. [2016]

2. England pubmed.ncbi.nlm.nih.gov

Intraoperative electron radiation therapy (IOERT) in patients with locally recurrent renal cell carcinoma. [2021]

3. Greece pubmed.ncbi.nlm.nih.gov

Radioablation of Hepatic Metastases from Renal Cell Carcinoma With Image-guided Interstitial Brachytherapy. [2019]

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

[Intraoperative electron irradiation (IORT) of urologic tumors. Initial results of a pilot study of local recurrences of renal cell cancers]. [2006]

5. Spain pubmed.ncbi.nlm.nih.gov

[Intraoperative radiotherapy in locally advanced carcinoma of the kidney: initial experience]. [2006]

6. Germany pubmed.ncbi.nlm.nih.gov

Prospective evaluation of CT-guided HDR brachytherapy as a local ablative treatment for renal masses: a single-arm pilot trial. [2020]

7. Poland pubmed.ncbi.nlm.nih.gov

Iodine-125 prostate seed brachytherapy in renal transplant recipients: an analysis of oncological outcomes and toxicity profile. [2021]

8. Germany pubmed.ncbi.nlm.nih.gov

Radioablation of liver malignancies with interstitial high-dose-rate brachytherapy : Complications and risk factors. [2022]

9. France pubmed.ncbi.nlm.nih.gov

[The recommendations of the International Commission on Radiological Protection (ICRP) for high-dose-rate brachytherapy and for permanent prostatic implants]. [2013]

10. Germany pubmed.ncbi.nlm.nih.gov

Transcatheter embolization of renal tumors with I-125 particles. [2004]

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

Management of primary and metastatic renal cell carcinoma by transcatheter embolization with iodine 125. [2019]

12. Czech Republic pubmed.ncbi.nlm.nih.gov

[The role of interstitial brachytherapy in multimodality management of solid tumors]. [2016]