Ablative Radioembolization of Renal Cell Carcinoma Trial

Summary

Renal cell carcinoma (RCC), the most common type of kidney cancer, is typically treated with surgery; however, there is no established therapy for patients who are not surgical candidates and who have tumours greater than 4.0 cm in size. Selective internal radiation therapy (SIRT) or radioembolization using radioactive spheres containing 90-Yttrium (Y-90) is successful at treating large tumours with high doses of radiation within the liver and might be similarly effective for treating larger RCC tumours in patients, particularly those who are not surgical candidates. This prospective study will enroll 16 participants with RCC who are not candidates for surgery and treat them with Y-90 radioembolization using a high-dose therapy to see if it is an effective cancer therapy. Primary outcome will be RCC treatment response 1 year after the Y-90 radioembolization. Additionally, the safety, tolerability, and impact on kidney function of the therapy will be monitored for all participants. Patients will be followed for a total of 5 years to evaluate long-term outcome in cancer control and safety of the treatment.

Eligibility

Inclusion Criteria:

* Patients willing to participate and provide written consent
* Patients 18 years of age and older
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤2
* Biopsy confirmed RCC \> 4.0 cm and no renal vein or IVC involvement (T1b or T2 disease)
* Not suitable for or declining standard of care nephrectomy or partial nephrectomy
* Adequate hepatic function, defined by the following laboratory results:
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × upper limit of normal (ULN) (or ≤5 × ULN if presence of liver metastases)
* Total bilirubin ≤3 × ULN
* Serum albumin ≥3.0 g/dL unless prothrombin time (PT) is within the normal range
* Adequate hematologic function, defined by the following laboratory results:
* Hemoglobin concentration ≥8.0 g/dL
* Absolute neutrophil count (ANC) ≥1000 cells/µL (≥1000 cells/mm3 )
* Platelets \>50 × 109 /L (100 × 103 /mm3 )
* For women of childbearing potential (WOCBP):
* Negative serum pregnancy test within 48 hours prior to the first dose of study treatment
* Agreement to use barrier contraception and a second form of highly effective contraception (Clinical Trials Facilitation Group \[CTFG\] 2020) while receiving study treatment and for 7 months following their last dose of study treatment. Alternatively, total abstinence is also considered a highly effective contraception method when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
* Sexually active male subjects must use a condom during intercourse while receiving treatment and for at least 120 days after the last dose of the study treatment and should not father a child during this period.
* Male study subjects whose sexual partners are WOCBP must also agree to use a second form of highly effective contraception (CTFG 2020) while receiving 90Y and for at least 4 months following their last dose. Alternatively, total abstinence is also considered a highly effective contraception method when this is in line with the preferred and usual lifestyle of the subject.
* Vasectomized men are also required to use a condom during intercourse, including with a male partner, to prevent delivery of the drug via seminal fluid.

Exclusion Criteria:

* Evidence of metastatic disease on CT or MRI
* Severely impaired renal function (GFR ≤ 30 mL/min/1.73m²) and not on dialysis
* Bilateral RCC without plan for definitive therapy of the contralateral lesion
* RCC that is locally recurrent at prior surgery or ablation site (new location in same or contralateral kidney is permitted)
* Prior or concurrent kidney radiation therapy or systemic immunotherapy/TKI
* Lung shunt with estimated lung radiation dose \> 30 Gy for single dose or \> 50 Gy total.
* Planning angiogram cone beam CT from all accessible feeding arteries shows lack of perfusion to all or portions of the RCC tumour such that, in the investigator's opinion, Y-90 radioembolization would result in substantial RCC tumour being untreated or receive an inadequate dose.
* Contraindication to arterial renal angiogram, or both CT and MRI contrast medium
* History of severe allergy to CT contrast medium or any study product ingredients that cannot be managed medically
* History of chronic lung disease with baseline oxygen saturation \< 90% or requiring home oxygen therapy.
* Congestive heart failure with ejection fraction \< 40%
* Presence of active infection, defined by the investigator as clinically significant.
* Any chronic condition that is severe or unstable and, in the opinion of the investigator, would put the patient at unacceptable risk of adverse event related to the Y-90 radioembolization procedure. Such conditions include but are not limited to: unstable angina, congestive heart failure, interstitial lung disease, severe gastrointestinal disease with diarrhea.
* Life expectancy \&gt; 1 year
* Pregnant or breast-feeding patient

Conditions3

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