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

Carcinoma, Renal Cell Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01107509
• Other study ID #: MIURCCEVERO
• Status: Completed
• Phase: N/A
• First received: April 20, 2010
• Last updated: April 2, 2018
• Start date: October 1, 2010
• Est. completion date: October 1, 2017

Study information

• Verified date: April 2018
• Source: St. Joseph's Healthcare Hamilton
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 1, 2017
• Est. primary completion date: October 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell

Intervention

Drug:
• everolimus
10 mg/ day everolimus in the form of an oral tablet for 12 weeks leading up to nephrectomy (with a 1-week perioperative washout period) in patients with locally advanced disease and re-initiating the drug postoperatively in patients with metastatic disease for up to 24 months, or until disease progression. Dosage may be reduced at any point to 5 mg/ day in the event of any grade 3/ 4 toxicity.

Locations

Country	Name	City	State
Canada	St. Joseph's Healthcare	Hamilton	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
St. Joseph's Healthcare Hamilton	McMaster University, Novartis Pharmaceuticals

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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