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Biomarkers of Tumor Angiogenesis and Response to Sunitinib Maleate in Renal Cell Carcinoma

18 Years
Open (Enrolling)
Kidney Cancer

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Trial Information

Biomarkers of Tumor Angiogenesis and Response to Sunitinib Maleate in Renal Cell Carcinoma


- To describe the gene expression of VEGF and non-VEGF angiogenic growth factor genes in
kidney cancer specimens from patients with metastatic renal cell carcinoma treated with
sunitinib malate.

- To describe the association between quantitative gene expression levels of VEGF and
non-VEGF angiogenic factors and clinical efficacy of this drug, as measured by
response, duration of response, and time to progression in these patients.

OUTLINE: Patients receive oral sunitinib malate once daily for 8 weeks. Within 2 weeks after
completion of neoadjuvant chemotherapy, patients undergo a nephrectomy and evaluation for
response to therapy. Beginning 4-8 weeks after surgery patients resume oral sunitinib malate
once daily for up to 12 months in the absence of disease progression or unacceptable

Patients with disease progression after 8 weeks of adjuvant treatment receive treatment off
study with other agents.

Viable (non-necrotic) tumor and non-tumor kidney tissue samples are obtained at the time of
nephrectomy for correlative biomarker studies. Tissue samples are analyzed for gene
expression of VEGF and non-VEGF angiogenic factors by real-time RT-PCR, western blot, and/or
IHC. Blood samples are obtained at baseline and at 4 and 8 weeks for evaluation of
circulating levels of VEGF and selected chemokines.

After completion of study therapy, patients are followed monthly.

Inclusion Criteria


- Diagnosis of clear cell renal cell carcinoma

- Metastatic disease

- Primary tumor is considered amenable to surgery

- Measurable disease, defined as ≥ 1 lesion that can be accurately measured in ≥ 1
dimension (longest diameter to be recorded) as > 20 mm by conventional techniques or
as > 10 mm by spiral CT scan

- No untreated brain metastases

- Treated brain metastases allowed provided lesion has been stable on two
consecutive CT or MRI scans separated by ≥ 2 months


- ECOG performance status 0-2

- Leukocytes ≥ 3,000/μL

- ANC ≥ 1,500/μL

- Platelet count ≥ 75,000/μL

- Hemoglobin ≥ 8.5 g/dL

- Total Bilirubin ≤ 2 times upper limits of normal (ULN)

- AST and ALT ≤ 2.5 times ULN

- Creatinine ≤ 2.5 times ULN

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- Able to undergo nephrectomy and treatment with sunitinib malate

- No history of allergic reactions attributed to compounds of similar chemical or
biological composition to sunitinib malate

- No uncontrolled intercurrent illness including, but not limited to, any of the

- Ongoing or active infection

- Symptomatic congestive heart failure

- Unstable angina pectoris

- Cardiac arrhythmia

- Psychiatric illness/social situations that would limit compliance with study


- No prior systemic treatment with sunitinib malate

- No other concurrent investigational agents

- No concurrent combination antiretroviral therapy for HIV-positive patients

- Concurrent medications or substances known to affect, or with the potential to
affect, the activity or pharmacokinetics of sunitinib malate allowed at the
discretion of the principal investigator

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Baseline gene expression of plasma biomarkers of tumor angiogenesis and response (i.e., VEGF and non-VEGF angiogenic growth factor genes)

Safety Issue:


Principal Investigator

Harry A. Drabkin, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Medical University of South Carolina



Study ID:




Start Date:

October 2008

Completion Date:

Related Keywords:

  • Kidney Cancer
  • stage IV renal cell cancer
  • clear cell renal cell carcinoma
  • recurrent renal cell cancer
  • Carcinoma, Renal Cell
  • Kidney Neoplasms



Hollings Cancer Center at Medical University of South CarolinaCharleston, South Carolina  29425