Clinical trial NCT01107509: Pilot Study of Neo-Adjuvant Everolimus to Treat Advanced Renal Cell Carcinoma - Analysis of Biomarkers
Official title: A Pilot Study of Neo-Adjuvant Everolimus in Patients With Advanced Renal Cell Carcinoma Undergoing Definitive Therapy With Radical Nephrectomy, or Cytoreductive Nephrectomy - Analysis of Serum and Tissue Biomarkers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Carcinoma, Renal Cell
Keywords: Renal cell carcinoma
Metastatic
everolimus
neo-adjuvant
biomarkers
nephrectomy
Locally advanced clear cell renal carcinoma
Metastatic clear cell renal carcinoma
Clear Cell Renal Carcinoma
Lead sponsor: St. Joseph's Healthcare Hamilton
Sponsor class: OTHER
Collaborators: name: McMaster University
name: Novartis Pharmaceuticals
First posted: 2010-04-21
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will gather data on potential biomarkers in the treatment of advanced renal cell carcinoma (kidney cancer) and investigate their use as indicators of disease response. The results could eventually enable doctors to match levels of therapy to levels of biomarker on an individual basis and to increase the chance of disease response in patients. This study will also test a new paradigm in the treatment approach of advanced kidney cancer by using the drug everolimus in a neo-adjuvant setting, with the overarching goal of decreasing cancer recurrence rates and improving patient outcomes and survival.


Eligibility criteria: Inclusion Criteria:

* At least 18 years of age and capable of giving informed consent
* Radiological evidence of RCC consisting of: CT scan with stage T2, T3, T3a, T3b, T4, or any stage T with N1/ 2 and/ or metastatic disease
* Having a nephrectomy and willing to have a kidney biopsy
* ECOG score 0 or 1
* Clear cell histology
* Negative for HIV, Hepatitis B, and Hepatitis C
* Negative pregnancy test for women of child-bearing potential

Exclusion Criteria:

* Stage T1 disease without metastases
* Abnormal laboratory values at screening within the following ranges:
* Absolute neutrophil count ≤ 1.5 × 109/ L; Platelet count ≤ 100 × 109/ L
* Leukocyte count ≤ 3 × 109/ L; Hemoglobin ≤ 80 g/ L; Serum creatinine ≥ 2.0 × the upper normal limit (UNL); Total bilirubin ≤ 1.5 × UNL; AST and ALT ≤ 3.0 × UNL
* Fasting serum cholesterol ≤ 9.0 mmol/ L; Fasting serum triglycerides ≥ 5.0 mmol/L
* Any major illness that, based on the investigator's judgment, will substantially increase the risk associated with a subject's participation in this study
* Other currently active malignancies
* Currently taking any medications known to interfere with the metabolism of everolimus
* Receiving anticoagulation with warfarin
* A history of pulmonary hypertension or interstitial lung disease

Primary outcomes:
measure: Response of primary tumor and metastases (if applicable) to everolimus in terms of tumor size and appearance (RECIST imaging response criteria) as determined by CT or MRI
timeFrame: From 6 weeks after starting neo-adjuvant everolimus until 1 year post-nephrectomy (or up to 24 months post-nephrectomy in metastatic patients)
Secondary outcomes:
measure: Effect of everolimus on blood and tissue biomarker expression (periodic blood testing and tissue samples from baseline renal biopsy and nephrectomy) in and among patients with locally advanced and metastatic disease with respect to baseline values
timeFrame: From baseline to 1 year post-nephrectomy for blood biomarker levels and from baseline to nephrectomy (week 12) for tissue biomarker levels
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: St. Joseph's Healthcare
state: Ontario
Study officials:
affiliation: McMaster University
name: Anil Kapoor, MD, FRCSC
role: PRINCIPAL_INVESTIGATOR
References: