ABOUT THIS STUDY
- Metastatic or unresectable Renal Cell Cancer (with clear cell component).
- Measurable disease by RECIST on CT with at least one measurable lesion 2 cm or greater in diameter, which is deemed to be assessable by PET imaging.
- At least 4 weeks after chemotherapy, radiotherapy or immunotherapy (6 weeks for nitrosourea drugs).
- Expected survival at least 3 months.
- Karnofsky performance status (KPS) of 70% or greater.
- Age 18 years or older.
- Vital laboratory parameters within normal, or protocol specified ranges.
- Left ventricular ejection fraction greater than 55% on GCBP scan.
- Systolic blood pressure ≤150mmHg and diastolic blood pressure ≤90mmHg
- Able to give written informed consent.
- Prior exposure to cG250 monoclonal antibody (exception: no circulating human
anti-chimeric antibody to cG250).
- Prior treatment with VEGF-targeting agents (e.g. bevacizumab) or multi-kinase
inhibitors (e.g. sorafenib) not including sunitinib. (Patients currently receiving
sunitinib may be eligible if tolerating a stable dose of sunitinib on a four week on /
two week off regimen, with toxicity due to sunitinib ≤ CTCAE grade 2; and for whom the
investigator deems it clinically reasonable to withhold sunitinib for at least four
weeks prior to commencement of study treatment.)
- Active central nervous system (CNS) metastases (exception: CNS metastases adequately
treated (surgery or radiotherapy) with no progression for at least three months).
- Known HIV positivity.
- Clinically significant heart disease.
- History of hypertension requiring hospitalisation.
- Other serious illnesses, eg, serious infections requiring antibiotics, bleeding
- Major surgery or radiation therapy within 4 weeks prior to, or planned within 6 weeks
of starting the study treatment. (Prior palliative radiotherapy to metastatic
lesion(s) permitted, provided at least one measurable lesion was not irradiated or has
progressed following radiotherapy)
- Severe haemorrhage within 4 weeks prior to starting the study treatment.
- Any of the following within the 12 months prior to study drug administration:
myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass
graft, symptomatic congestive heart failure, cerebrovascular accident or transient
ischemic attack, or pulmonary embolism.
- Pre-existing thyroid abnormality with unstable thyroid function despite medication.
- Ongoing moderate to severe cardiac dysrhythmias, any severity of atrial fibrillation,
or prolongation of the QTc interval to greater than 450 msec for males or 470 msec for
- Participation in a clinical trial involving another investigational agent within 4
- Pregnancy or breastfeeding.
- Women of childbearing potential not using a medically acceptable means of
- Psychiatric or addictive disorders that may compromise the ability to give informed
- Not available for follow-up assessment.
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