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

NCT ID: NCT01107509

Last Updated: 2018-04-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-01
• Study Completion Date: 2017-10-01

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.

Conditions

Carcinoma, Renal Cell

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Neo-adjuvant everolimus

Group Type: EXPERIMENTAL

everolimus

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Afinitor; RAD-001

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

McMaster University

OTHER

Sponsor Role: collaborator

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

St. Joseph's Healthcare Hamilton

OTHER

Sponsor Role: lead

Responsible Party

Anil Kapoor

MD, FRCSC

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anil Kapoor, MD, FRCSC

Role: PRINCIPAL_INVESTIGATOR

McMaster University

Locations

St. Joseph's Healthcare

Hamilton, Ontario, Canada

Countries

Canada

Other Identifiers

MIURCCEVERO

Identifier Type: -

Identifier Source: org_study_id