Nearly 40% of patients diagnosed with renal cell carcinoma are at high risk of recurrence after nephrectomy (surgery to remove all or part of the kidney) within 5 years. Currently, there is no approved treatment available for these patients until their disease has become metastatic (spread to other places). This study is comparing a drug (chimeric monoclonal antibody cG250) to a placebo in order to investigate a treatment for patients who are at high risk of their cancer coming back after surgery.

Patients with surgically removed renal cell carcinoma of the clear cell type who meet the following criteria: -Not more than 12 weeks post-nephrectomy -Must have no evidence of residual disease -One of the following diagnosed stages of tumor: -T3a/T3b/T3c N0/X M0 or T4N0/X M0 -Any T stage and N positive disease (in the lymph nodes) and M0 (not in the bone) -T1bN0/X M0 or T2N0/X M0, each with Fuhrman grading III or greater -No prior organ transplant -No prior radiation, immunotherapy or chemotherapy within the last 5 years -No other cancers in the last 5 years, except surgically-cured non-melanoma skin cancer or cervical carcinoma in situ. Other criteria may apply and will be discussed and evaluated prior to enrollment.

If you are eligible, your participation will
require weekly 15 minute infusions for 6 months.
These visits will last approximately 1 hour
each. All study procedures must be done at the
downtown Virginia Mason Clinic. Baseline imaging
scans, blood, urine and questionnaires are
required in order to verify eligibility.

You will be followed for five years after
enrollment in this study via scans,
questionnaires, and physical exams. After the
first six months, visits will be every three
months until the end of year 2, every six months
during year 3 and 4, and a final visit at year
5. The scans required at these visits are
considered to be standard of care every six
months, and will be charged to your insurance at
these time points. All procedures that are
performed specifically for the study will be paid
for by the sponsor of this study.

You will be asked to thoroughly review, discuss,
and sign an Informed Consent Form prior to any
research related activity. Please contact us for
more information.

Study Summary:

Detailed Study Description:

Study Design: Interventional, Blinded
Phase of Study: Phase III
Study Type: Interventional
Condition or Study Focus: Renal Cell Carcinoma
Intervention Type: Drug
Intervention Name: cG250
Gender: Male and Female
Age group: Interventional
Sponsor: Wilex AG