Neo-adjuvant Temsirolimus in Patients With Advanced Renal Cell Carcinoma
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.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- The rate of change in response of primary tumor and metastases (if applicable)in participants. [ 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). ] [ Designated as safety issue: No ]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.
- Average time for disease progression. [ Time Frame: At every visit; baseline, weekly visits, and follow-up. ] [ Designated as safety issue: Yes ]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.
- Quality of life data [ Time Frame: Baseline, weekly visits, follow-up ] [ Designated as safety issue: No ]
|Study Start Date:||September 2008|
|Estimated Study Completion Date:||September 2014|
|Estimated Primary Completion Date:||August 2014 (Final data collection date for primary outcome measure)|
|Experimental: Temsirolimus (pre-surgery)||
Drug: Temsirolimus (pre surgery)
Temsirolimus will be given to patients 12 weeks prior to surgery (with a one week off period right before the surgery date).
Other Name: Temsirolimus
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01404104
|St. Joseph's Healthcare Hamilton|
|Hamilton, Ontario, Canada, L8N 4A6|
|Principal Investigator:||Anil Kapoor, MD||McMaster Institute of Urology - St. Joseph's Healthcare Hamilton|