Neo-adjuvant Temsirolimus in Patients With Advanced Renal Cell Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01404104
Recruitment Status : Completed
First Posted : July 27, 2011
Last Update Posted : July 27, 2016
McMaster University
Information provided by (Responsible Party):
Anil Kapoor, St. Joseph's Healthcare Hamilton

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Renal Cell Carcinoma Drug: Temsirolimus (pre surgery) Not Applicable

Detailed Description:
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  (Clinical Trial)
Actual Enrollment : 11 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : September 2008
Actual Primary Completion Date : August 2014
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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). ]
    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.

Secondary Outcome Measures :
  1. Average time for disease progression. [ Time Frame: At every visit; baseline, weekly visits, and follow-up. ]
    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.

  2. Quality of life data [ Time Frame: Baseline, weekly visits, follow-up ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • At least 18 years old and capable of giving informed consent.
  • Patient has radiological evidence of RCC consisting of: CT scan with stage T2, T3, T3a, T4, or any stage T with N1/2 and/or metastatic disease.
  • Patient is already having a nephrectomy.
  • Adequate cardiac function as assessed by electrocardiogram (ECG).
  • Patient is will to have a kidney biopsy at baseline/screening.
  • Patient has scored a 0 or 1 on the ECOG.
  • Patient is negative for HIV, Hepatitis B, Hepatitis C
  • If patient is a woman of child-bearing potential, they have to have a negative pregnancy test.

Exclusion Criteria:

  • Patient has stage T1 disease without metastases.
  • Patient has abnormal laboratory values at screening within the following ranges:
  • Absolute neutrophil count ≤1.5 x 10(9)/L; Platelet count ≤ 100 x 10(9)/L
  • Leukocyte count ≤ 3 x 10(9)/L; Hemoglobin ≤ 80 g/L
  • Serum creatinine ≥ 2.0 x the upper normal limit (UNL)
  • Total bilirubin ≤ 1.5 x UNL; AST and ALT ≤ 3.0 x UNL
  • Fasting serum cholesterol ≤ 9.0 mmol/L
  • Fasting serum triglycerides ≤ 5.0 mmol/L
  • Patients with a known hyper-sensitivity to Temsirolimus.
  • Other currently active malignancies.
  • Currently taking any medications known to interfere with the metabolism of Temsirolimus.
  • Patients receiving anticoagulation with warfarin.
  • Patients with a history of pulmonary hypertension or interstitial lung disease.
  • Unstable angina as judged by the primary investigator, or any recent MI in the last 180 days.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01404104

Canada, Ontario
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, Canada, L8N 4A6
Sponsors and Collaborators
St. Joseph's Healthcare Hamilton
McMaster University
Principal Investigator: Anil Kapoor, MD McMaster Institute of Urology - St. Joseph's Healthcare Hamilton

Responsible Party: Anil Kapoor, MD, FRCSC, St. Joseph's Healthcare Hamilton Identifier: NCT01404104     History of Changes
Other Study ID Numbers: IIS-003-09
First Posted: July 27, 2011    Key Record Dates
Last Update Posted: July 27, 2016
Last Verified: July 2016

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents