Neo-adjuvant Temsirolimus in Patients With Advanced Renal Cell Carcinoma

NCT01404104

Last updated date
Study Location
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, L8N 4A6, Canada
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Renal Cell Carcinoma
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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Advanced Information
Descriptive Information
Brief Title  ICMJE Neo-adjuvant Temsirolimus in Patients With Advanced Renal Cell Carcinoma
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Renal Cell Carcinoma
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: Temsirolimus (pre-surgery)
Intervention: Drug: Temsirolimus (pre surgery)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 11, 2012)
11
Original Estimated Enrollment  ICMJE
 (submitted: July 26, 2011)
20
Actual Study Completion Date  ICMJE August 2014
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01404104
Other Study ID Numbers  ICMJE IIS-003-09
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Anil Kapoor, St. Joseph's Healthcare Hamilton
Study Sponsor  ICMJE St. Joseph's Healthcare Hamilton
Collaborators  ICMJE
  • McMaster University
  • Pfizer
Investigators  ICMJE
Principal Investigator:Anil Kapoor, MDMcMaster Institute of Urology - St. Joseph's Healthcare Hamilton
PRS Account St. Joseph's Healthcare Hamilton
Verification Date July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP