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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


N/A
18 Years
N/A
Open (Enrolling)
Both
Renal Cell Carcinoma

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Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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

Outcome Description:

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.

Outcome 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).

Safety Issue:

No

Principal Investigator

Anil Kapoor, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

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

Authority:

Canada: Health Canada

Study ID:

IIS-003-09

NCT ID:

NCT01404104

Start Date:

September 2008

Completion Date:

July 2013

Related Keywords:

  • Renal Cell Carcinoma
  • Carcinoma
  • Carcinoma, Renal Cell

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