Neo-adjuvant Temsirolimus in Patients With Advanced Renal Cell Carcinoma

Renal Cell Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01404104
• Other study ID #: IIS-003-09
• Status: Completed
• Phase: N/A
• First received: July 19, 2011
• Last updated: July 26, 2016
• Start date: September 2008
• Est. completion date: August 2014

Study information

• Verified date: July 2016
• Source: St. Joseph's Healthcare Hamilton
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Renal Cell Carcinoma

Intervention

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).

Locations

Country	Name	City	State
Canada	St. Joseph's Healthcare Hamilton	Hamilton	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
St. Joseph's Healthcare Hamilton	McMaster University, Pfizer

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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.	Yes
Secondary	Quality of life data		Baseline, weekly visits, follow-up	No