Pilot Study of Neo-Adjuvant Everolimus to Treat Advanced Renal Cell Carcinoma - Analysis of Biomarkers

Not Applicable

Completed

• Conditions: Carcinoma, Renal Cell
• Interventions: Drug: everolimus

• Registration Number: NCT01107509
• Lead Sponsor: St. Joseph's Healthcare Hamilton

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-04-20
• Study First Submitted QC: 2010-04-20
• Study First Posted: 2010-04-21
• Study Start: 2010-10-01
• Primary Completion: 2017-10-01
• Study Completion: 2017-10-01
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-02
• Last Update Posted: 2018-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Neo-adjuvant everolimus	everolimus	-

Primary Outcome Measures

Name	Time	Method
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	From 6 weeks after starting neo-adjuvant everolimus until 1 year post-nephrectomy (or up to 24 months post-nephrectomy in metastatic patients)

Secondary Outcome Measures

Name	Time	Method
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	From baseline to 1 year post-nephrectomy for blood biomarker levels and from baseline to nephrectomy (week 12) for tissue biomarker levels

Trial Locations

Locations (1)

St. Joseph's Healthcare; 🇨🇦 Hamilton, Ontario, Canada