Vandetanib to Treat Advanced Kidney Cancer

Stopped early · Phase 2

Conditions studied: Advanced Clear Cell Renal Carcinoma

In brief

Background: * One way tumors are able to grow is by forming new blood vessels that supply it with nutrients and oxygen. * Vandetanib (ZD6474) is an experimental drug that blocks certain proteins on the surface of tumor and blood vessel cells that are involved with the formation of new blood vessels. * Blocking these proteins may prevent the tumor cells or blood vessels from continuing to grow. Objectives: * To determine whether vandetanib can cause tumors to shrink or stabilize in patients with advanced kidney cancer. * To determine how vandetanib may work in people with kidney cancer and to develop tests that may be helpful in studying kidney cancer. Eligibility: -Patients 18 years of age or older with advanced clear cell kidney cancer whose disease has worsened after treatment with one or more of the following drugs: sunitinib, sorafenib, interleukin-2 and temsirolimus; or patients who have had to stop treatment with these drugs due to unacceptable side effects; or patients who are unable to receive standard treatment. Design: * Patients take a vandetanib pill once a day in 28-day cycles. * Patients are followed in the clinic every 2 weeks during the first month of treatment and then every 4 weeks for a physical examination, blood and urine tests, electrocardiogram and a review of any drug side effects. * Patients have imaging scans (computed tomography (CT) or magnetic resonance imaging (MRI)) about every 8 weeks to monitor tumor growth. MRI scans are also done to look at tumor blood flow when treatment begins, 24 hours after the first dose of treatment, and again about 4 and 8 weeks after starting treatment * Optional tumor biopsies (surgical removal of a sample of tumor tissue) may be done before starting vandetanib treatment and after 4 weeks of treatment to look for drug effects on the tumor.

Key facts

Study ID

NCT01372813

Run by

National Cancer Institute (NCI)

People needed

3

Starts

2007-12-01

Expected to finish

2010-06-01

Last updated by the study team

2015-10-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Prior malignancy of other histology, with the exception of cervical carcinoma in situ or adequately treated basal or squamous cell carcinoma of the skin, or any other malignancy for which the patient has not required active treatment for more than three years.
• Patients with VHL disease will be excluded from this study.
• Patients may not be receiving any other investigational agents or have received treatment with a non-approved or investigational drug within 30 days before Day 1 of study treatment.
• Patients with known brain metastases (except when adequately treated greater than or equal to 6 months before enrollment with no evidence of recurrence).
• Use of 5HT-3 antagonists because of the potential effect on corrected Q wave, T wave (QTc) interval.
• Any concurrent medication that may cause QTc prolongation or induce Torsades de Pointes (Appendix C).
• Drugs listed in Appendix C, Table 2, that in the investigator's opinion cannot be discontinued, are allowed, but must be monitored closely.
• Clinically significant cardiac event (including symptomatic heart failure, myocardial infarction or angina) within 3 months of entry or presence of any cardiac disease that in the opinion of the Principal Investigator increases the risk of ventricular arrhythmia.
• Patients with a history a major cardiac event more than 3 months prior to enrolment will be evaluated by a cardiologist to assess cardiac status and potential for increased risk with ZD6474 therapy.
• History of clinically significant arrhythmia [including multifocal premature ventricular contraction (PVC), bigeminy, trigeminy, ventricular tachycardia] that is symptomatic or requires treatment (CTCAE grade 3) or symptomatic/ asymptomatic sustained ventricular tachycardia.
• Uncontrolled atrial fibrillation. Atrial fibrillation controlled on medication is not excluded.
• Presence of Left bundle branch block.
• Previous history of QTc prolongation while taking other medications that required discontinuation of that medication.
• Congenital long QT syndrome or first degree relative with unexplained sudden death under the age of 40 years.
• QTc with Bazett's correction that is unmeasurable, or greater than or equal to 480 msec on screening ECG.
• If a patient has QTc greater than or equal to 480 msec on screening ECG, the screen ECG may be repeated twice (at least 24 hours apart).
• The average QTc from the three screening electrocardiograms (ECGs) must be less than 480 msec in order for the patient to be eligible for the study).
• Patients who are receiving a drug that has a risk of QTc prolongation (see Appendix C, Group/Table 2) are excluded if QTc is greater than or equal to 460 msec.
• Potassium concentration less than 4.0 mEq/L, calcium (ionized calcium or adjusted for albumin), or magnesium concentrations outside normal limits despite optimal supplementation/correction.
• Left ventricular ejection fraction less than 45 percent measured by multiple gated acquisition scan (MUGA) or echocardiogram (ECHO).
• Hypertension not controlled by medical therapy (systolic blood pressure greater than 150 mmHg or diastolic blood pressure greater than 100 mmHg).
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• Patient known to be human immunodeficiency virus (HIV)-positive and requiring antiretroviral therapy.
• Currently active diarrhea that may affect the ability of the patient to absorb ZD6474 or tolerate further diarrhea.
• Pregnant women are excluded from this study because ZD6474 is an anti-angiogenic agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with ZD6474, breastfeeding should be discontinued if the mother is treated with ZD6474.

Where it is running

• National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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