SLM + Axitinib for Clear Cell RCC

Launched by MOHAMMED MILHEM · Aug 25, 2015

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with advanced metastatic clear cell renal cell carcinoma (CCRCC), a type of kidney cancer that has spread to other parts of the body. The trial combines two medications: L-selenomethionine, which may help stop tumor growth by blocking the formation of new blood vessels, and axitinib, which works by blocking certain enzymes that cancer cells need to grow. The main goal of the trial is to find out the best dose of L-selenomethionine when used with axitinib and to learn about any side effects that these treatments might cause.

To be eligible for this study, participants must be at least 18 years old and have advanced CCRCC that has already progressed after at least one other treatment. They should also have certain health indicators, like stable kidney and liver function, and a life expectancy of at least 12 weeks. Participants will need to provide written consent and may be asked to undergo a biopsy. It's important to note that the trial is currently active but not recruiting new patients. If you or a loved one are considering participation, it could offer access to a potentially beneficial treatment while contributing to important cancer research.

Gender

ALL

Eligibility criteria

• 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.