Neo-adjuvant Temsirolimus in Patients With Advanced Renal Cell Carcinoma

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

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 Overview

• Status: Completed
• Conditions: Renal Cell Carcinoma
• Intervention / Treatment: Drug: Temsirolimus (pre surgery)

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
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8N 4A6
      • St. Joseph's Healthcare Hamilton

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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 Names: Temsirolimus

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At every visit; baseline, weekly visits, and follow-up.
Quality of life data		Baseline, weekly visits, follow-up

Collaborators and Investigators

• Sponsor: St. Joseph's Healthcare Hamilton
• Collaborators: Pfizer; McMaster University
• Investigators: Principal Investigator: Anil Kapoor, MD, McMaster Institute of Urology - St. Joseph's Healthcare Hamilton

Study record dates

Study Major Dates

• Study Start: September 1, 2008
• Primary Completion (Actual): August 1, 2014
• Study Completion (Actual): August 1, 2014

Study Registration Dates

• First Submitted: July 19, 2011
• First Submitted That Met QC Criteria: July 26, 2011
• First Posted (Estimate): July 27, 2011

Study Record Updates

• Last Update Posted (Estimate): July 27, 2016
• Last Update Submitted That Met QC Criteria: July 26, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Kidney Diseases; Urologic Diseases; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Kidney Neoplasms; Carcinoma, Renal Cell; Carcinoma; Physiological Effects of Drugs; Anti-Infective Agents; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Anti-Bacterial Agents; Antibiotics, Antineoplastic; Antifungal Agents; Sirolimus
• Other Study ID Numbers: IIS-003-09