Neo-adjuvant Temsirolimus in Patients With Advanced Renal Cell Carcinoma

NCT ID: NCT01404104

Last Updated: 2016-07-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-09-30
• Study Completion Date: 2014-08-31

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.

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.

Conditions

Renal Cell Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Temsirolimus (pre-surgery)

Group Type: EXPERIMENTAL

Temsirolimus (pre surgery)

Intervention Type: DRUG

Temsirolimus will be given to patients 12 weeks prior to surgery (with a one week off period right before the surgery date).

Interventions

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).

Intervention Type: DRUG

Other Intervention Names

Temsirolimus

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

McMaster University

OTHER

Sponsor Role: collaborator

Pfizer

INDUSTRY

Sponsor Role: collaborator

St. Joseph's Healthcare Hamilton

OTHER

Sponsor Role: lead

Responsible Party

Anil Kapoor

MD, FRCSC

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anil Kapoor, MD

Role: PRINCIPAL_INVESTIGATOR

McMaster Institute of Urology - St. Joseph's Healthcare Hamilton

Locations

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, Canada

Countries

Canada

Other Identifiers

IIS-003-09

Identifier Type: -

Identifier Source: org_study_id