SLM + Axitinib for Kidney Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine the optimal dose and understand the side effects of combining L-selenomethionine, a supplement that may inhibit tumor growth, with axitinib, a cancer drug. It targets advanced metastatic clear cell renal cell carcinoma, a challenging type of kidney cancer that has spread. Researchers hope this combination will surpass the effectiveness of current treatments. Patients with metastatic kidney cancer who have tried other treatments might be suitable candidates for this trial. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering patients the opportunity to be among the first to receive this new combination therapy.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop all current medications, but you cannot take certain drugs that affect liver enzymes, like some antibiotics and antifungals. There is a 2-week period required after your last systemic treatment before starting the trial.
Is there any evidence suggesting that this treatment is likely to be safe for humans?
Research has shown that the combination of L-selenomethionine (SLM) and axitinib is generally well-tolerated by patients. In earlier studies, patients took up to 4000 micrograms of SLM with axitinib, and most managed it well. Common side effects included tiredness, diarrhea, high blood pressure, nausea, loss of appetite, cough, protein in the urine, and weight loss. These side effects are typical for cancer treatments and did not stop the study.
Axitinib is already used to treat advanced kidney cancer, and doctors are familiar with managing its side effects. Overall, the treatment with SLM and axitinib shows promising safety data, making it a potential option for those with advanced kidney cancer.12345Why are researchers excited about this trial's treatments?
Researchers are excited about the combination of Selenomethionine (SLM) and axitinib for kidney cancer because it introduces the use of SLM, an antioxidant amino acid that may help enhance the effects of axitinib. While axitinib is already a standard treatment targeting blood vessel growth in tumors, SLM could potentially improve its efficacy and reduce side effects by protecting healthy cells. This dual approach aims to not only inhibit tumor growth more effectively but also improve the overall treatment experience for patients.
What evidence suggests that this trial's treatments could be effective for advanced metastatic kidney cancer?
This trial will evaluate the combination of Selenomethionine (SLM) and Axitinib for treating advanced kidney cancer. Research suggests that L-selenomethionine (SLM) may inhibit tumor growth by preventing new blood vessel formation. In one study, patients taking a 4,000 microgram dose showed a 55.6% positive response, with effects lasting about 18.4 months. Axitinib has also demonstrated potential in treating various cancers, including kidney cancer. Specifically, in some studies, tumors shrank in about 70 out of 361 patients, with the disease remaining stable for an average of 12.4 months. Combining these treatments in this trial might offer a more effective approach to treating advanced kidney cancer.678910
Who Is on the Research Team?
Mohammed Milhem, MBBS
Principal Investigator
University of Iowa Hospitals & Clinics
Are You a Good Fit for This Trial?
Adults with advanced metastatic clear cell renal cell carcinoma (CCRCC) who've had at least one systemic therapy can join this trial. They must have a target lesion, adequate organ function, and an ECOG status of 0-2. Pregnant women, recent major surgery patients, those with untreated brain metastases or uncontrolled hypertension are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Dose-Escalation Part 1
SLM will be given twice daily for 14 days followed by once daily dosing in combination with axitinib 5 mg twice daily with titration according to package insert. Treatment will continue until disease progression or unacceptable toxicity.
Expansion Part 2
Patients will be treated at the maximum tolerated dose (MTD) of SLM determined in the Escalation Part 1. SLM will be given orally twice daily for 14 days, followed by once daily dosing in combination with axitinib 5 mg twice daily with titration according to package insert. Treatment will continue until disease progression or unacceptable toxicity.
Pilot Phase
Dosing will begin at dose level 3 (4000, 5000, or 6000 mcg SLM calculated based on patients' BSA). SLM will be given orally twice daily for 14 days. Each cohort will enroll 2 evaluable patients.
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Axitinib
- Selenomethionine (SLM)
Axitinib is already approved in European Union, United States, United Kingdom for the following indications:
- Renal cell carcinoma
- Advanced renal cell carcinoma
- Advanced renal cell carcinoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
Mohammed Milhem
Lead Sponsor
Bilal G. Rahim
Lead Sponsor
Yousef Zakharia
Lead Sponsor
Pfizer
Industry Sponsor
Albert Bourla
Pfizer
Chief Executive Officer since 2019
PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki
Patrizia Cavazzoni
Pfizer
Chief Medical Officer
MD from McGill University