Temsirolimus is a drug that is being studied to possibly treat kidney cancer. It works by starving the cancer of nutrients, by cutting off the blood supply, which is hoping to shrink the cancer. This study will look at the experimental use of temsirolimus, 12 weeks prior to the surgical removal of the entire kidney or a portion of the kidney that is involved by the tumor.
This study will also find out whether or not there are certain biological factors that show up in patients during their treatment with this drug. This will be able to predict how their disease will respond to the therapy (biomarkers), and this will possibly allow anti-cancer therapies to be developed in the future to tailor to a patient's needs.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
11
Temsirolimus will be given to patients 12 weeks prior to surgery (with a one week off period right before the surgery date).
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, Canada
The rate of change in response of primary tumor and metastases (if applicable)in participants.
Rate of Change in response of primary tumor and metastases (if applicable) to neo-adjuvant Temsirolimus in terms of tumour size and appearance (RECIST imaging response criteria) as determined by CT or MRI.
Time frame: Baseline, Weeks 1-12, follow up every 3 months for years 1 and 2, and every 6 months for following three years (5 years in total).
Average time for disease progression.
Patients will be seen at baseline and 12 weeks prior to surgical removal of the entire kidney or a portion of the kidney involved by tumour. If there has been metastases then patients might remain on the study treatment with temsirolimus following the surgery, for a maximum of 24 months or until disease progression. The total duration of the study is up to 5 years.
Time frame: At every visit; baseline, weekly visits, and follow-up.
Quality of life data
Time frame: Baseline, weekly visits, follow-up
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