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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
McMaster University
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Anil Kapoor, St. Joseph's Healthcare Hamilton
ClinicalTrials.gov Identifier:
NCT01107509
First received: April 20, 2010
Last updated: August 23, 2012
Last verified: August 2012
History of Changes
  Purpose

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.


Condition Intervention
Carcinoma, Renal Cell
 Drug: everolimus

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by St. Joseph's Healthcare Hamilton:

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 [ 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) ] [ Designated as safety issue: No ]

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 [ Time Frame: From baseline to 1 year post-nephrectomy for blood biomarker levels and from baseline to nephrectomy (week 12) for tissue biomarker levels ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: October 2010
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Neo-adjuvant everolimus 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.
Other Names:
  • Afinitor
  • RAD-001

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01107509

Locations
Canada, Ontario
St. Joseph's Healthcare
Hamilton, Ontario, Canada, L8N 4A6
Sponsors and Collaborators
St. Joseph's Healthcare Hamilton
McMaster University
Novartis Pharmaceuticals
Investigators
Principal Investigator: Anil Kapoor, MD, FRCSC McMaster University
  More Information

No publications provided

Responsible Party: Anil Kapoor, MD, FRCSC, St. Joseph's Healthcare Hamilton
ClinicalTrials.gov Identifier: NCT01107509     History of Changes
Other Study ID Numbers: MIURCCEVERO
Study First Received: April 20, 2010
Last Updated: August 23, 2012
Health Authority: Canada: Health Canada

Keywords provided by St. Joseph's Healthcare Hamilton:
Renal cell carcinoma
Metastatic
everolimus
neo-adjuvant
biomarkers
 nephrectomy
Locally advanced clear cell renal carcinoma
Metastatic clear cell renal carcinoma
Clear Cell Renal Carcinoma

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Adjuvants, Immunologic
 Everolimus
Sirolimus
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Immunosuppressive Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Antifungal Agents
Anti-Infective Agents
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on May 19, 2013