None listed
Conditions
Brief summary
The treatment known as selective internal radiation therapy, or SIRT has been used in human patients since 1998 for the treatment of liver cancer. This study will be the first time that SIRT treatment has been used in human patients for the treatment of kidney cancer. The primary purpose of this study is to test the safety of SIRT as a treatment for patients with kidney cancer (also known as renal cell carcinoma) that is not suitable for treatment using the standard treatment options available. While SIRT treatment has been used for over a decade to treat liver cancer, it has not been used before to treat kidney cancer. In this study, four separate groups of patients will be entered into the study. The four groups of patients will each receive a certain dose of selective internal radiation therapy for their kidney cancer. The dose of radiation will start with a low dose in the first group of patients. The dose of radiation will then proceed to successively higher doses of radiation for patient groups two, three and four, if it has been shown safe to do so. SIRT treatment uses SIR-Spheres microspheres, which are tiny beads about a third the width of a human hair that emit radiation that is designed to kill tumours. Millions of SIR-Spheres are injected by a specially trained doctor known as an Interventional Radiologist into the blood vessel(s) that supply blood to the tumours. After being injected into the blood vessels that supply the tumours, the SIR-Spheres lodge in the tiny blood vessels of the tumour, where they emit their radiation directly into the tumour, with the aim of destroying the tumour.
Interventions
This is a pilot study that will be the first in human study to evaluate the feasibility, safety,
toxicity and potential effectiveness of selective internal radiation therapy (SIRT) using SIR-Spheres
microspheres as a treatment for patients with renal cell carcinoma that is not suitable
for curative therapy by conventional means.
Patients will be serially recruited into dose escalating cohorts: 75Gy, 100Gy, 150Gy, 200Gy, 300Gy intended radiation dose to the tumour. If no dose limiting toxicity is
This is a pilot study that will be the first in human study to evaluate the feasibility, safety, toxicity and potential effectiveness of selective internal radiation therapy (SIRT) using SIR-Spheres microspheres as a treatment for patients with renal cell carcinoma that is not suitable for curative therapy by conventional means. Patients will be serially recruited into dose escalating cohorts: 75Gy, 100Gy, 150Gy, 200Gy, 300Gy intended radiation dose to the tumour. If no dose limiting toxicity is evident following completion of recruitment into the 300Gy cohort, then a final cohort of six patients may be recruited. In this final cohort, the angiographic endpoint of “imminent stasis” in the renal artery will serve as the endpoint for delivery of SIR-Spheres microspheres, regardless of actual dose delivered.
Sponsors
Sirtex Technology Pty Ltd
Study design
Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
In order to be considered eligible for the study, patients must fulfil the following inclusion criteria: (a) Willing, able and mentally competent to provide written informed consent. (b) Histologically confirmed primary renal cell carcinoma of the kidney. (c) Unequivocal and measurable MRI evidence of primary renal cell carcinoma that either: 1) is not suitable for treatment by surgical resection, local ablation or other conventional techniques with curative intent; or 2) does not require immediate treatment by surgical resection, local ablation or other conventional techniques with curative intent, at the time of study entry. (d) Metastatic disease other than untreated central nervous system (CNS) metastases is permitted. (e) All imaging evidence used as part of the screening process must be less than 45 days old at the time of delivery of protocol SIRT therapy. (f) Suitable for protocol therapy as determined by both the Medical Oncology and Surgical Urology Investigators. (g) Other than radiotherapy, prior therapy for primary renal cell carcinoma is allowed, provided that such therapy was administered and completed at least 45 days prior to entry into this study. (h) World Health Organisation (WHO) performance status 0 – 2. (i) Adequate haematological and renal function as follows: Haematological Neutrophils > 1.5 x 109/L Platelets > 100 x 109/L Renal Calculated glomerular filtration rate (GFR) > 30 ml/min/1.73m2 (j) Aged 18 years or older. (k) Female patients must be postmenopausal, or surgically sterile, or if sexually active using an acceptable method of contraception. (l) Male patients must be surgically sterile or if sexually active and having a pre-menopausal female partner must be using an acceptable method of contraception. (m) Life expectancy of at least 3 months without any active treatment. (n) Renal arterial anatomy suitable for implantation of SIR-Spheres microspheres, as assessed by visceral and renal angiogram.
Exclusion criteria
Patients will be considered ineligible for the study for any of the following reasons: (a) Previous radiotherapy delivered to the kidney or within a 5cm margin. (b) Subsequent therapy planned to be administered within 60 days of the delivery of protocol SIRT therapy. (c) Renal-to-lung shunt fraction that indicates potential exposure to the lung to an absorbed radiation dose of more than 25Gy. (d) Inadequate renal function as defined by estimated GFR <30 ml/min/1.7m2. (e) Intercurrent disease that would render the patient unsuitable for treatment according to this protocol. (f) Equivocal, immeasurable, or unevaluable primary renal cell carcinoma in the kidney. (g) Pregnant or breast feeding.
Outcome results
None listed