Neo-adjuvant Temsirolimus in Patients With Advanced Renal Cell Carcinoma

NCT01404104 | Completed

• 1 other identifier: IIS-003-09
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Renal Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Average time for disease progression.

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

• Quality of life data

  Baseline, weekly visits, follow-up

Study Arms (1)

Temsirolimus (pre-surgery)

EXPERIMENTAL

Drug: Temsirolimus (pre surgery)

Interventions

Temsirolimus (pre surgery) DRUG

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

Also known as: Temsirolimus

Temsirolimus (pre-surgery)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• St. Joseph's Healthcare Hamilton: lead
• McMaster University: collaborator
• Pfizer: collaborator

Study Sites (1)

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, L8N 4A6, Canada

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

temsirolimus

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Anil Kapoor, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, FRCSC

Study Record Dates

• First Submitted: July 19, 2011
• First Posted: July 27, 2011
• Study Start: September 1, 2008
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: July 27, 2016

Record last verified: 2016-07

Locations

CA (1)