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Investigator(s):
W. Marston Linehan, M.D. Principal Investigator Phone: 301-496-6353 linehanm@mail.nih.gov
Referral Contact(s):
David Draper, R.N. Research Nurse Phone: 301-435-5614 draperd@mail.nih.gov

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Primary Eligibility:

• Histologically confirmed clear cell renal cell carcinoma
• Metastatic or unresectable disease
• Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT scan
• Must have received prior sunitinib or sorafenib (discontinued for disease progression or unacceptable toxicity) OR be ineligible to receive sunitinib or sorafenib
• Patients who discontinued sunitinib or sorafenib for life-threatening toxicities that are also known to occur with vandetanib are not eligible
• Must have failed, be ineligible to receive, or have declined treatment with high-dose IL-2
• No von Hippel-Lindau disease
• No known brain metastases except when adequately treated ≥ 6 months prior to study entry and no evidence of recurrence
• Recovered from all prior therapy
• No more than two prior agents known to inhibit VEGF or VEGF receptors
• No concurrent 5HT-3 antagonists
• No concurrent drugs that could induce torsades de pointes
• No concurrent antiretroviral therapy for HIV-positive patients
• No concurrent potent inducers of CYP3A4 function
• No blood donation during and for 3 months after the last dose of study drug
• > 18 years of age
• ECOG 0–2
• WBC ≥ 3,000/mm³
• ANC ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³
• Creatinine ≤ 1.5 x upper limit of normal (ULN) or creatinine clearance ≥ 50 mL/min
• AST and ALT < 2.5 x ULN
• Total bilirubin < 1.5 x ULN (3 x ULN for patients with Gilbert’s disease)
• Alkaline phosphatase ≤ 2.5 x ULN (5 x ULN if liver metastases are present)
• Potassium concentration ≥ 4.0 mEq/L
• Calcium (ionized calcium or adjusted for albumin) and magnesium concentrations normal (optimal supplementation/correction allowed)
• Not pregnant or nursing; fertile patients must use effective contraception during and for ≥ 3 months after completion of study treatment
• No prior malignancy except cervical carcinoma in situ or adequately treated basal cell or squamous cell carcinoma of the skin, or any other malignancy for which the patients has not required active treatment for > 3 years
• No medical condition that would preclude study participation
• No active diarrhea that may affect the ability of the patient to absorb study drug or tolerate further diarrhea
• No hypersensitivity to vandetanib or its excipients

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Treatment Plan:

• Patients receive oral vandetanib once daily on Days 1–28
• Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity; CT scans and other studies to assess disease status are performed approximately every eight weeks
• Patients undergo dynamic contrast-enhanced MRI at baseline, 24 hours after the first dose of study drug, and at the end of courses 1 and 2 to measure tumor vascular flow and permeability
• Blood is collected at Weeks 1 and 3 of Course 1, at the beginning of Course 2 and each subsequent course, and then at the completion of study treatment
• Patients also need to have EKGs and blood work done every week for the first eight weeks
• After completion of study treatment, patients may be followed periodically if required

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Additional Information:

• This trial will be conducted at the NIH Clinical Center in Bethesda, MD. It is open to patients who meet the eligibility requirements, regardless of where they live in the United States.
• There is no charge for medical care received at NIH Clinical Center.
• FAQs about this study - provides information for patients about the trial such as frequency and duration of visits, costs, how to enroll, treatment plan.
• PDQ (Physicians Data Query) - provides additional details about this study for health care providers.

Reviewed: 12/4/08
Updated: 12/4/08