Why Participate?
Why Participate?
Access treatment options that may not be available outside of the research setting
Improve personal health; if treatment works, can be among the first to benefit
Contribute to developing the next generation of drugs for kidney cancer
Make a difference
Understanding Clinical Trials
Clinical trials are the means to advance medical treatments. At their apex, they involve comparing a new treatment to the current treatment standard. While developed to advance treatment, new drugs or procedures are not always better and they may have more side effects. At the Kidney Cancer Program, clinical trials are carefully selected and vetted by a group of expert doctors. Only trials perceived to have a high potential to advance kidney cancer management are activated.
Inasmuch as clinical trials involve non-standard-of-care interventions and deal with patient health information, there are always risks. While efforts are made to ensure that the interventions are reasonable and clinical trials are reviewed by independent scientific (Protocol Review and Monitoring Committee) and ethical (Institutional Review Board Committee) bodies, there is no substitute for careful review of the informed consent document and obtaining answers to any questions that may arise.
Essential for executing clinical trials ethically, informed consent is the process whereby potential participants are informed about the clinical trial, its risks and the potential benefits. Careful document review is imperative to make an informed decision. Informed consent and other clinical trial documents are approved by the IRB (Institutional Review Board), a third party independent from the investigators that ensures that trials adhere to appropriate ethical standards.
Types of Trials
Types of Trials
Oncology drug trials are typically divided into:
First time a drug is tested in a human. Typically involves testing progressively higher doses of a drug while closely monitoring for toxicity. Starting dose is determined based on studies in animals, erring on the side of safety over activity. Often the main objective is the identification of the maximal tolerated dose/regimen, which will be later evaluated to ascertain activity. Typically 10 to 50 participants.
Phase 2 trials seek to determine whether the drug regimen (dose and schedule) has activity against a particular tumor type. Typically fewer than 100 participants.
These trials, which are the foundation for regulatory bodies such as the FDA to approve new treatments, compare a new drug regimen to the standard of care. Ideally, they are randomized and blinded. Randomization and blindness to the treatment allocation minimize the possibility that the results of the trial would be influenced by the physician investigators or the participants. Typically more than 500 participants.
Why Participate?
Access treatment options that may not be available outside of the research setting
Improve personal health; if treatment works, can be among the first to benefit
Active roll in treatment decisions
Help improve medical care for others and advance cancer treatments
Make a difference
Understanding Clinical Trials
Provide high-quality care
- Volunteers not receiving newest treatment being tested receive the best standard treatment currently available
New Treatments not always better
- Standard care available may end up being as good or better than new treatment approach
Not everyone benefits
- New treatment approaches that show benefits may not work for all volunteers
- Even proven standard treatments do not help everyone
Informed Consent
- Learning about all of the key facts of the research study, along with patients’ rights, before deciding to participate
- Responsibility of research staff to ensure participants understand all aspects, given ample time to decide, feel comfortable
- Additional information, visit NCI
Information coming soon
Types of Trials
- May include:
- medical drugs or devices
- medical procedures
- behavior changes or modifications (ex: diet)
- May compare new treatment approach to:
- one currently available
- a placebo, OR
- no intervention
- May compare two or more currently available
Information coming soon
Information coming soon
Information coming soon
UTSW Clinical Trials
Biomarkers/Imaging
| UTSW CLINICAL TRIALS | ID | PRINCIPAL INVESTIGATOR | STATUS | CONTACT |
|---|---|---|---|---|
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Multiparametric MRI in T1b-T4 Renal Masses |
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Recruiting |
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Advanced MR Imaging in the Characterization of Renal Cell Carcinoma: Correlation with Pathology and Gene Expression Profiles |
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Recruiting |
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A Prospective Comparison of Whole-body Magnetic Resonance Imaging, Sodium Fluoride Positron Emission Tomography, and Whole-body Bone Scintigraphy for Diagnosis of Renal Cell Carcinoma Osseous Metastases |
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Recruiting |
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89Zr-DFO-Atezolizumab ImmunoPET/CT in Patients With Locally Advanced or Metastatic Renal Cell Carcinoma |
Recruiting |
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Prognostic Significance of Circulating Tumor Cells in Patients with Renal Cell Carcinoma |
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Recruiting |
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A Prospective Study to Evaluate Quantitative Non-Contrast Perfusion Using Arterial Spin Labeled Magnetic Resonance Imaging for Assessment of Therapy Response in Metastatic Renal Cell Carcinoma |
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Recruiting |
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UTSW CLINICAL TRIALS | ID | PRINCIPAL INVESTIGATOR | STATUS | CONTACT |
|---|---|---|---|---|
Multiparametic MRI in T1b-T4 Renal Masses | Recruiting | Michael Fulkerson | ||
Advanced MR Imaging in the Characterization of Renal Cell Carcinoma: Correlation with Pathology and Gene Expression Profiles | Recruiting | Michael Fulkerson | ||
A Prospective Comparison of Whole-body Magnetic Resonance Imaging, Sodium Fluoride Positron Emission Tomography, and Whole-body Bone Scintigraphy for Diagnosis of Renal Cell Carcinoma Osseous Metastases | Recruiting | Sydney Haldeman | ||
89Zr-DFO-Atezolizumab ImmunoPET/CT in Patients with Locally Advanced or Metastatic Renal Cell Carcinoma | Recruiting | Kelli Key | ||
Exploratory Study of PT2385 PET/CT in Patients with Renal Cell Carcinoma | NCT04989959 | Recruiting | Sydney Haldeman | |
Prognostic Significance of Circulating Tumor Cells in Patients with Renal Cell Carcinoma | Recruiting | Allison Beaver, R.N. | ||
A Prospective Study to Evaluate Quantitative Non-Contrast Perfusion Using Arterial Spin Labeled Magnetic Resonance Imaging for Assessment of Therapy Response in Metastatic Renal Cell Carcinoma | Recruiting | Sydney Haldeman |
Localized RCC
UTSW CLINICAL TRIALS | ID | PRINCIPAL INVESTIGATOR | STATUS | CONTACT |
|---|---|---|---|---|
Success of Active Surveillance in Patients with Untreated Small Renal Masses with the Option of Delayed Treatment | Recruiting | Allison Beaver, R.N. | ||
Recruiting | Samantha Mannala | |||
Safety Lead-in Phase II Trial of Neo-Adjuvant SABR for IVC Tumor Thrombus in Newly Diagnosed RCC | Recruiting | Samantha Mannala |
| UTSW CLINICAL TRIALS | ID | PRINCIPAL INVESTIGATOR | STATUS | CONTACT |
|---|---|---|---|---|
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Success of Active Surveillance in Patients with Untreated Small Renal Masses with the Option of Delayed Treatment |
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Recruiting |
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Recruiting |
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Recruiting |
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Neoadjuvant
UTSW CLINICAL TRIALS | ID | PRINCIPAL INVESTIGATOR | STATUS | CONTACT |
|---|---|---|---|---|
Active, not recruiting | Allison Beaver, R.N. |
| UTSW CLINICAL TRIALS | ID | PRINCIPAL INVESTIGATOR | STATUS | CONTACT |
|---|---|---|---|---|
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Active, not recruiting |
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Adjuvant
| UTSW CLINICAL TRIALS | ID | PRINCIPAL INVESTIGATOR | STATUS | CONTACT |
|---|---|---|---|---|
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Active, not recruiting
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Advanced – No Prior Treatment
UTSW CLINICAL TRIALS | ID | PRINCIPAL INVESTIGATOR | STATUS | CONTACT |
|---|---|---|---|---|
Phase II Trial of SABR for Patients with Oligometastatic Renal Cell Carcinoma | Recruiting | Samantha Mannala | ||
Recruiting | Allison Beaver, R.N. | |||
Recruiting | Christina Carrigan | |||
Closed to accrual | Allison Beaver, R.N. |
| UTSW CLINICAL TRIALS | ID | PRINCIPAL INVESTIGATOR | STATUS | CONTACT |
|---|---|---|---|---|
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Recruiting |
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Recruiting |
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Recruiting |
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Closed to accrual |
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Advanced – Prior Treatment
UTSW CLINICAL TRIALS | ID | PRINCIPAL INVESTIGATOR | STATUS | CONTACT |
|---|---|---|---|---|
Recruiting | Samantha Mannala | |||
Recruiting | Samantha Mannala | |||
Recruiting | Pamela Kurian, M.S. | |||
Recruiting | Laurin Priddy | |||
Recruiting | Renee Davis |
| UTSW CLINICAL TRIALS | ID | PRINCIPAL INVESTIGATOR | STATUS | CONTACT |
|---|---|---|---|---|
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Recruiting |
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Recruiting |
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Recruiting |
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Recruiting |
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Recruiting |
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Advanced – Prior PD1/PDL1
UTSW CLINICAL TRIALS | ID | PRINCIPAL INVESTIGATOR | STATUS | CONTACT |
|---|---|---|---|---|
Recruiting | Christina Carrigan | |||
Phase II BMS FRACTION Study to Test Combination Treatments | Closed to accrual | Allison Beaver, R.N. | ||
A Study of Belzutifan (MK-6482) in Participants with Advanced Renal Cell Carcinoma | Active, not recruiting | Christina Carrigan, RN |
| UTSW CLINICAL TRIALS | ID | PRINCIPAL INVESTIGATOR | STATUS | CONTACT |
|---|---|---|---|---|
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Recruiting |
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Phase II BMS FRACTION Study to Test Combination Treatments |
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Closed to accrual
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Phase 1b Dose-Finding Study of ARO-HIF-2 in Patients with Advanced Clear Cell Renal Cell Carcinoma |
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Recruiting |
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Recruiting |
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Recruiting |
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Recruiting |
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Leading Provider
National Kidney Cancer Clinical Trials Consortium
Along with M.D. Anderson Cancer Center (lead), Cleveland Clinic, and Beth Israel Deaconess/Harvard Cancer Center, the UT Southwestern Kidney Cancer Program is a founding member of the first National Kidney Cancer Clinical Trials Consortium, an initiative spearheaded by the Congressionally Directed Kidney Cancer Research Program under the leadership of Dr. Brugarolas during his tenure as Chair of the Integration Panel.
