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

• Status: Terminated
• Trial end date: 2012-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ludwig Institute for Cancer Research
• Collaborators: Heidelberg Pharma AG; Pfizer; Wilex
• Treatments: Antibodies; Antibodies, Monoclonal; Immunoglobulins; Sunitinib

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Prior exposure to cG250 monoclonal antibody (exception: no circulating human anti-chimeric antibody to cG250).

• 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.)

• 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 disorders.

• 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 corrected QT interval (QTc) to greater than 450 millisecond for males or 470 millisecond for females.

• Participation in a clinical trial involving another investigational agent within 4 weeks.

• Pregnancy or breastfeeding.

• Women of childbearing potential not using a medically acceptable means of contraception.

• Psychiatric or addictive disorders that may compromise the ability to give informed consent.

• Not available for follow-up assessment.