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Neo-adjuvant Temsirolimus in Patients With Advanced Renal Cell Carcinoma

Primary Purpose

Renal Cell Carcinoma

Status

Completed

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Temsirolimus (pre surgery)

About this trial

This is an interventional treatment trial for Renal Cell Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

St. Joseph's Healthcare Hamilton

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Temsirolimus (pre-surgery)

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Quality of life data

Full Information

NCT ID

NCT01404104

First Posted

July 19, 2011

Last Updated

July 26, 2016

Sponsor

St. Joseph's Healthcare Hamilton

Collaborators

McMaster University, Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT01404104

Brief Title

Neo-adjuvant Temsirolimus in Patients With Advanced Renal Cell Carcinoma

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 Type

Interventional

2. Study Status

Record Verification Date

July 2016

Overall Recruitment Status

Completed

Study Start Date

September 2008 (undefined)

Primary Completion Date

August 2014 (Actual)

Study Completion Date

August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

St. Joseph's Healthcare Hamilton

Collaborators

McMaster University, Pfizer

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Renal Cell Carcinoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

11 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Temsirolimus (pre-surgery)

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Temsirolimus (pre surgery)

Other Intervention Name(s)

Temsirolimus

Intervention Description

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

Primary Outcome Measure Information:

Title

The rate of change in response of primary tumor and metastases (if applicable)in participants.

Description

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).

Secondary Outcome Measure Information:

Title

Average time for disease progression.

Description

Time Frame

At every visit; baseline, weekly visits, and follow-up.

Title

Quality of life data

Time Frame

Baseline, weekly visits, follow-up

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Anil Kapoor, MD

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

St. Joseph's Healthcare Hamilton

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

L8N 4A6

Country

Canada

12. IPD Sharing Statement

Learn more about this trial

Neo-adjuvant Temsirolimus in Patients With Advanced Renal Cell Carcinoma

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