What side effects are associated with this type of intervention?

Common treatments for kidney cancer include surgery, radiation therapy, and systemic therapies such as immunotherapy and targeted therapy. Interstitial brachytherapy, a form of internal radiation therapy, can cause side effects like localized pain, bleeding, and infection at the insertion site, as well as potential damage to nearby organs. External radiation therapy may lead to fatigue, skin irritation, and gastrointestinal issues. Systemic therapies, including immunotherapy and targeted therapy, often result in side effects such as fatigue, hypertension, diarrhea, and skin rashes. Severe toxicities can include cardiovascular issues and nephrotoxicity, particularly with high-dose regimens.

What prior FDA approvals exist?

The FDA has approved several treatments for kidney cancer, including targeted therapies and immunotherapies. Notable approvals include tyrosine kinase inhibitors like sunitinib and pazopanib, which target specific pathways in cancer cells, and immune checkpoint inhibitors such as nivolumab and pembrolizumab, which enhance the body's immune response against cancer. While interstitial brachytherapy (internal radiation therapy) is being studied for its efficacy in treating unresectable or unablatable kidney cancer, it is not yet a standard FDA-approved treatment for this condition. Other radiation-based treatments, such as external beam radiation therapy, are more commonly used in certain cases of kidney cancer.

What other types of research exist?

Promising novel alternatives to interstitial brachytherapy for kidney cancer patients include: 1) Immunotherapy combinations such as nivolumab and ipilimumab, which have shown efficacy in advanced renal cell carcinoma. 2) Targeted therapies like cabozantinib combined with atezolizumab, which have demonstrated positive results in clinical trials. 3) Pembrolizumab with bevacizumab, another combination showing promise in metastatic renal cell carcinoma. These alternatives offer potential benefits and should be discussed with a healthcare provider.

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Brachytherapy

Interstitial Radiation Therapy for Kidney Cancer

Q: What is the mechanism of action of this treatment?

The most common treatments for kidney cancer include interstitial brachytherapy, immunotherapy, and targeted therapies. Interstitial brachytherapy involves placing a radiation source directly into or near the tumor, which helps to eradicate cancer cells by damaging their DNA, leading to cell death. This is particularly useful for patients with unresectable or unablated tumors. Immunotherapy, such as checkpoint inhibitors, works by enhancing the body's immune response against cancer cells, making it a crucial option for advanced stages of kidney cancer. Targeted therapies, like tyrosine kinase inhibitors, block specific molecules involved in tumor growth and angiogenesis, thereby inhibiting cancer progression. These treatments are vital as they offer options for patients who cannot undergo surgery and provide personalized approaches to manage and potentially reduce tumor burden.

Phase 1 & 2

Recruiting

Led By Albert J Chang

Research Sponsored by Jonsson Comprehensive Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Good performance status (Eastern Cooperative Oncology Group [ECOG]) < 2

No definitive evidence of locally advanced (nodal or tumor thrombus) or distant (metastatic) disease

Must not have

Prior surgery or radiation therapy to the operative site

Need for urgent treatment of renal cancer due bleeding, pain, or paraneoplastic syndrome

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 1 year

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects include localized pain, swelling at the treatment site, bleeding, infection risk from invasive procedure, fatigue due to radiation exposure, potential damage to surrounding tissues or organs near the treated area.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can do most of my daily activities without help.

Select...

My cancer has not spread to nearby lymph nodes or distant parts of my body.

Select...

I am a woman who can have children and my pregnancy test before starting therapy was negative.

Select...

My cancer can be treated with brachytherapy according to my radiation oncologist.

Select...

I cannot or do not want to have surgery to cure my condition.

Select...

I have not received any systemic treatment for kidney cancer.

Select...

My tumor is mostly solid.

Select...

My kidney cancer was confirmed through a biopsy.

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My kidney tumor can be treated with a special type of radiation.

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I have chosen to receive internal radiation therapy for my kidney cancer.

Select...

My cancer cannot be treated with targeted destruction methods.

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My tumor is between 4 and 10 cm in size.

Select...

My lesion has been growing for over 6 months and is expected to grow more than 4mm a year.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

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

Select...

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

Select...

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

Select...

I have an untreated cancer that is not kidney cancer.

Select...

I have a history of unusual bleeding or had a recent bleeding episode.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Dose limiting toxicity (DLT)

One year (12-month) linear growth rate

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (interstitial brachytherapy)Experimental Treatment1 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.

0 / 18Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for kidney cancer include interstitial brachytherapy, immunotherapy, and targeted therapies. Interstitial brachytherapy involves placing a radiation source directly into or near the tumor, which helps to eradicate cancer cells by damaging their DNA, leading to cell death. This is particularly useful for patients with unresectable or unablated tumors. Immunotherapy, such as checkpoint inhibitors, works by enhancing the body's immune response against cancer cells, making it a crucial option for advanced stages of kidney cancer. Targeted therapies, like tyrosine kinase inhibitors, block specific molecules involved in tumor growth and angiogenesis, thereby inhibiting cancer progression. These treatments are vital as they offer options for patients who cannot undergo surgery and provide personalized approaches to manage and potentially reduce tumor burden.

Prospective evaluation of CT-guided HDR brachytherapy as a local ablative treatment for renal masses: a single-arm pilot trial.Role of radiotherapy in the treatment of renal cell cancer: updated and critical review.