Neo-adjuvant Temsirolimus in Patients With Advanced Renal Cell Carcinoma
NCT01404104
ABOUT THIS STUDY
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Adult Trials: 18+ Years
- 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.
- 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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| 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 | 11 | |||
| Original Estimated Enrollment ICMJE | 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:
Exclusion Criteria:
| |||
| Sex/Gender ICMJE |
| |||
| 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 |
| |||
| Investigators ICMJE |
| |||
| 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 | ||||