A Pilot Study of Neo-adjuvant Temsirolimus in Patients With Advanced Renal Cell Carcinoma Undergoing Definitive Therapy With Radical Nephrectomy, or Cytoreductive Nephrectomy: Analysis if Serum and Tissue Biomarkers
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.
Interventional
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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.
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).
No
Anil Kapoor, MD
Principal Investigator
McMaster Institute of Urology - St. Joseph's Healthcare Hamilton
Canada: Health Canada
IIS-003-09
NCT01404104
September 2008
July 2013
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