Neo-adjuvant Temsirolimus in Patients With Advanced Renal Cell Carcinoma

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
McMaster University
Pfizer
Information provided by (Responsible Party):
Anil Kapoor, St. Joseph's Healthcare Hamilton
ClinicalTrials.gov Identifier:
NCT01404104
First received: July 19, 2011
Last updated: July 14, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
Renal Cell Carcinoma
Drug: Temsirolimus (pre surgery)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by St. Joseph's Healthcare Hamilton:

Primary Outcome Measures:
  • The rate of change in response of primary tumor and metastases (if applicable)in participants. [ 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). ] [ Designated as safety issue: No ]
    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. [ Time Frame: At every visit; baseline, weekly visits, and follow-up. ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Baseline, weekly visits, follow-up ] [ Designated as safety issue: No ]

Enrollment: 11
Study Start Date: September 2008
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Temsirolimus (pre-surgery) 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).
Other Name: Temsirolimus

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01404104

Locations
Canada, Ontario
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, Canada, L8N 4A6
Sponsors and Collaborators
St. Joseph's Healthcare Hamilton
McMaster University
Pfizer
Investigators
Principal Investigator: Anil Kapoor, MD McMaster Institute of Urology - St. Joseph's Healthcare Hamilton
  More Information

No publications provided

Responsible Party: Anil Kapoor, MD, FRCSC, St. Joseph's Healthcare Hamilton
ClinicalTrials.gov Identifier: NCT01404104     History of Changes
Other Study ID Numbers: IIS-003-09
Study First Received: July 19, 2011
Last Updated: July 14, 2014
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Carcinoma
Adenocarcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Sirolimus
Everolimus
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 22, 2014