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Study of Sunitinib in Subjects With High Risk Renal Cell Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01070186
Recruitment Status : Withdrawn (No participants were enrolled.)
First Posted : February 17, 2010
Last Update Posted : July 31, 2012
Information provided by:
Jonsson Comprehensive Cancer Center

Brief Summary:
This study is designed to explore the molecular modulatory effect of Sunitinib when given in a neoadjuvant setting prior to radical or partial nephrectomy. The study will evaluate aforementioned outcomes in 30 patients at a dose of 50mg/day for 4 weeks followed by surgery 2-4 weeks following the last dose.

Condition or disease Intervention/treatment Phase
Renal Cell Carcinoma Drug: Sunitinib Other: Tumor biopsy Procedure: Nephrectomy Other: Biomarkers Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II, Open Label, Single Center Study of Sunitinib in Subjects With High Risk Renal Cell Carcinoma
Study Start Date : October 2010

Arm Intervention/treatment
Experimental: Treatment
See intervention descriptions
Drug: Sunitinib
50mg/day for 4 weeks
Other Name: Sutent

Other: Tumor biopsy
Conducted prior to administration of sunitinib therapy

Procedure: Nephrectomy
Nephrectomy 2-4 weeks after last dose of Sunitinib

Other: Biomarkers

Biomarker evaluation of blood prior to treatment, after 4 weeks of Sunitinib administration, and every three months for a year after surgery.

Biomarker evaluation of tissue prior to 4 week administration of Sunitinib

Primary Outcome Measures :
  1. Time to clinical recurrence after surgery for high risk localized disease. [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Toxicity of Sunitinib when administered as neoadjuvant therapy prior to surgery [ Time Frame: 1 year ]
    Toxicities will be graded using the NCI Common Toxicity Criteria, version 3.0

  2. Effect of Sunitinib on pretreatment serum levels of Vascular Endothelial Growth Factor (VEGF). Tissue levels (biopsy and pathological specimen) of total VEGF, HIF-alpha, microvessel density, and apoptotic indices (TUNNEL Staining) [ Time Frame: 1 year ]
  3. Radiographically quantifiable evaluation of changes in cellular disorganization (marker of necrosis) and perfusion parameters before and during the administration of Sunitinib. [ Time Frame: 1 year ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients must be at least 18 years of age
  • Must be eligible to undergo a radical or partial nephrectomy
  • Clinical stage T1b, T2, T3, T4 and/or N1 disease as documented by abdomen/pelvis CT scan, or MRI and chest x-ray or CT chest
  • Patients must have a performance status on the ECOG scale of 0-1
  • Patients must have a pretreatment wbc > 3.0, granulocyte count > 1000/mm3, hemoglobin > 8.5 g/dL, platelet count > 100,000/mm3 and a normal PT and PTT
  • Patients must have a serum creatinine < 2.0 mg/dL
  • Patients must have adequate hepatic function with a serum bilirubin < upper limit of normal and AST/ALT < 2.5 x upper limit of normal

Exclusion Criteria:

  • Radiographic evidence of metastatic disease
  • Prior administration of immunotherapy/biotherapy/hormonal or radiation for renal cell carcinoma
  • Active secondary malignancies (other than basal cell carcinoma of the skin)
  • Serious, nonhealing wound, ulcer, or bone fracture
  • Clinically significant cardiovascular disease, New York Heart Association Grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication or Grade II or greater peripheral vascular disease within 1 year preceding Day 0
  • Any history or radiologic evidence of central nervous system disease
  • Active infection requiring parenteral antibiotics at the time of the first Sunitinib administration
  • Current or recent (within the 10 days preceding Day 0) use of oral or parenteral anticoagulants (except as required to maintain patency of preexisting, permanency indwelling IV catheters), or aspirin
  • Current, recent (within the 4 weeks preceding Day 0), or planned participation in another experimental drug study
  • Screening clinical laboratory values:

    • ANC of < 1000/uL
    • Platelet count of < 100,000/uL
    • Total bilirubin > 2.0 mg/dL
    • AST or ALT > 2.5 times the upper limit of normal
    • Serum creatinine of > 2.0 mg/dL
    • Hemoglobin of < 9 gm/dL (may be transfused to maintain or exceed this level)
    • Ongoing cardiac dysrhythmias of NCI CTCAE Version 3.0 grade > 2
    • Prolonged QTc interval on baseline EKG
    • Uncontrolled hypertension (>150/100 mm Hg despite optimal medical therapy)
    • Pre-existing thyroid abnormality with thyroid function that cannot be maintained in the normal range with medication
    • Patients receiving CYP3A4 inducers or inhibitors; patients should not take grapefruit juice or St. John's Wort while on the study
    • History of psychiatric disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect the interpretation of the results of the study or render the subject at high risk from treatment complications
    • Unable to take medication by mouth

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01070186

Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
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Principal Investigator: Fairooz Kabbinavar, M.D. University of California, Los Angeles
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Responsible Party: Fairooz Kabbinavar, MD / Principal Investigator, UCLA Jonsson Comprehensive Cancer Center Identifier: NCT01070186    
Other Study ID Numbers: 09-07-068
First Posted: February 17, 2010    Key Record Dates
Last Update Posted: July 31, 2012
Last Verified: July 2012
Keywords provided by Jonsson Comprehensive Cancer Center:
Kidney Cancer
Additional relevant MeSH terms:
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Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action