Clinical Trial · NCT00520533

Study of Safety and Functional Imaging of cG250 and Sunitinib in Patients With Advanced Renal Cell Carcinoma

Overview

This clinical trial explores the safety, efficacy, and effects on functional imaging of cG250 monoclonal antibody (mAb) administered intravenously weekly in combination with daily oral sunitinib, in patients with advanced renal cell carcinoma.

Sponsor

Olivia Newton-John Cancer Research Institute

Phase

Phase 1

Contacts

A/Prof Ian D Davis, FRACP, FAChPM, MBBS, PhD (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT00520533

Eligibility

Inclusion

Expected survival at least 3 months.
Left ventricular ejection fraction greater than 55% on GCBP scan.
Vital laboratory parameters within normal, or protocol specified ranges.
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.
Karnofsky performance status (KPS) of 70% or greater.
At least 4 weeks after chemotherapy, radiotherapy or immunotherapy (6 weeks for nitrosourea drugs).
Metastatic or unresectable Renal Cell Cancer (with clear cell component).
Systolic blood pressure ≤150mmHg and diastolic blood pressure ≤90mmHg.

Exclusion

Active central nervous system (CNS) metastases (exception: CNS metastases adequately treated (surgery or radiotherapy) with no progression for at least three months).
Ongoing moderate to severe cardiac dysrhythmias, any severity of atrial fibrillation, or prolongation of the corrected QT interval (QTc) to greater than 450 millisecond for males or 470 millisecond for females.
Prior treatment with vascular endothelial growth factor (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.)