Could selenium boost kidney cancer treatment?
NCT ID NCT02535533
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This trial tested a combination of two drugs—axitinib (a standard kidney cancer drug) and seleniomethionine (a form of selenium)—in 45 adults with advanced clear cell renal cell carcinoma that had spread. The goal was to find the safest dose and see if the combination could shrink tumors. Participants took seleniomethionine alone for two weeks, then added axitinib. The study focused on side effects and early signs of effectiveness.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- axitinib and seleniomethionine
- What this could lead to
- If it works, this combination could offer a new treatment option for advanced kidney cancer that has stopped responding to other therapies.
- What could go wrong
- This was an early-phase trial with only 45 participants, so results may not apply to all patients. The main goal was safety, not proof of effectiveness.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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45 people
The number who actually took part.
- Started
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Jan 2016
- Finished
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Apr 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: Each patient must meet all of the following criteria to be enrolled in this study: * Histologically and radiologically confirmed advanced metastatic CCRCC in patients who have had at least one prior systemic therapy, which can include axitinib for the dose escalation part. In the expansion and pilot phases, patients with prior axitinib are allowed, as long as the last dose of axitinib was longer than 6 months ago. * Written and voluntary informed consent. * At least one Response Evaluation Criteria In Solid Tumors (RECIST)-defined target lesion. \*Patient must have documented disease progression. * Renal function (creatinine level within normal institutional limit, or creatinine clearance \>15 mL/min/1.73 m2 for patients with creatinine levels above institutional normal, calculated using the Cockcroft-Gault formula). * Liver function (AST/ALT \<2.5 X institutional upper limit of normal OR \< 5 x institutional upper limit of normal in cases of liver metastases; Total bilirubin ≤ 1.5 times ULN.) * Adequate hematological lab values including; * Absolute Neutrophil Count (ANC) ≥ 1.0 x 109/L * Platelets ≥ 100 x 109/L * Hemoglobin ≥ 7.0 g/dL * Eastern Cooperative Oncology Group (ECOG) performance status of 0 (fully active, able to carry on all pre-disease performance without restriction), 1 (restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, such as light housework or office work) or 2 (Ambulatory and capable of all self-care but unable to carry out any work activities; up and about more than 50% of waking hours). * Age of at least 18 years. * Life expectancy of 12 weeks and more. * 2 weeks or more since end of previous systemic treatment (4 weeks or more for bevacizumab plus interferon-alfa). 3 days wash out for palliative radiation. * Must have a safely accessible biopsy per treating physician and the provider performing that biopsy. Patient must agree to have this biopsy done as outlined in the calendar. If patient does not have safely accessible biopsy, the patient may still be enrolled per investigator discretion. Exclusion Criteria: Patients eligible for this study must not meet any of the following criteria: * Patients with prior malignancies of the same or different tumor type in the last 5 years and patients with concurrent malignancies of the same or different tumor type UNLESS the natural history of the disease or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational drug. * Symptomatic untreated metastases in the central nervous system. * Subject that is pregnant or lactating. * Pre-existing uncontrolled hypertension defined as \> 150/90 mm Hg with medication. * Present use or anticipated need for cytochrome P450 (CYP) 3A4-inhibiting, CYP3A4-inducing drugs (e.g., ketoconazole, itraconazole, clarithromycin, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, and voriconazole, rifampin, phenytoin, carbamazepine, rifabutin, rifapentin, phenobarbital, and St. John's wort, bosentan, efavirenz, etravirine, modafinil, and nafcillin).Myocardial infarction, uncontrolled angina, congestive heart failure, or cerebrovascular accident within previous 6 months. Subjects with history of deep vein thrombosis or pulmonary embolism, at provider discretion. * Major surgery within 4 weeks of starting study treatment. * Known HIV or acquired immunodeficiency syndrome-related disease.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242, United States