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

Primary Purpose

Carcinoma, Renal Cell

Status

Completed

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

everolimus

About this trial

This is an interventional treatment trial for Carcinoma, Renal Cell focused on measuring Renal cell carcinoma, Metastatic, everolimus, neo-adjuvant, biomarkers, nephrectomy, Locally advanced clear cell renal carcinoma, Metastatic clear cell renal carcinoma, Clear Cell Renal Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

St. Joseph's Healthcare

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Neo-adjuvant everolimus

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT01107509

First Posted

April 20, 2010

Last Updated

April 2, 2018

Sponsor

St. Joseph's Healthcare Hamilton

Collaborators

McMaster University, Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT01107509

Brief Title

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

2. Study Status

Record Verification Date

April 2018

Overall Recruitment Status

Completed

Study Start Date

October 1, 2010 (Actual)

Primary Completion Date

October 1, 2017 (Actual)

Study Completion Date

October 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

St. Joseph's Healthcare Hamilton

Collaborators

McMaster University, Novartis Pharmaceuticals

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Neo-adjuvant everolimus

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

everolimus

Other Intervention Name(s)

Afinitor, RAD-001

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Time Frame

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 Measure Information:

Title

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Anil Kapoor, MD, FRCSC

Organizational Affiliation

McMaster University

Official's Role

Principal Investigator

Facility Information:

Facility Name

St. Joseph's Healthcare

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

L8N 4A6

Country

Canada

12. IPD Sharing Statement

Learn more about this trial

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

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