Kidney Cancer - Ajuvant Trial – NON-METASTATIC DISEASE

	UROLOGY MAIN SITE	GEN. ADULT UROLOGY	UROLOGIC ONCOLOGY	MALE UROLOGY	TRANSPLANT PROGRAM
	PELVIC MEDICINE, INCONTINENCE & RECONST. SURGERY		PEDIATRIC UROLOGY	MIN. INVASIVE SURGERY

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Clinical Trial Details

Trial Information

Trial:

Kidney Cancer - Ajuvant Trial – NON-METASTATIC DISEASE

Co-Investigator(s):	Arie Belldegrun, MD;

This trial is currently accepting new patient applications. (Apply)

Objective

A RANDOMIZED DOUBLE BLIND PHASE III STUDY TO EVALUATE ADJUVANT cG250 TREATMENT VERSUS PLACEBO IN PATIENTS WITH CLEAR CELL RCC AND HIGH RISK OF RECURRENCE

The purpose of this trial is to evaluate the efficacy and safety of adjuvant cG250 treatment versus placebo in patients post nephrectomy (no more than six weeks) with surgically completely resected clear cell renal cell carcinoma at high risk of recurrence. Chimeric monoclonal antibody (cG250) detects a cell-surface antigen (MN antigen) on renal cancer cells. It is anticipated that the therapeutic effects of cG250 treatment in patients with metastatic RCC may be maximized in earlier stages of the disease. Patients meeting the criteria for high risk of recurrence will be randomized to either a weekly 15 minute IV infusion with cG250 or a placebo over a period of 24 weeks. Previous studies have demonstrated that the antibody is very well tolerated with minimal toxicity.

Principal investigator: Fairooz Kabbinavar - Hematology-Oncolory

Trial Design

Patient Eligibility

Inclusion Criteria:

Prior (partial or total) nephrectomy of primary renal cell carcinoma with documented clear cell histology
No evidence of macroscopic and microscopic residual disease (enlarged lymph nodes should be removed)
Patients diagnosed of having one of the following (referring to TNM classification, 6th edition UICC, 2002 ):
- Risk group I: T3aN0/XM0 or T3bN0/XM0 or T3cN0/XM0 or T4N0/XM0
- Risk group II: any T stage and N+ disease and M0
- Risk group III: T1bN0/XM0 or T2N0/XM0, each with grading G * 3 (Fuhrman or any other nuclear grading system with at least 3 grades)
ECOG of 0-1
Not more than 12 weeks between date of nephrectomy and randomization

EXCLUSION CRITERIA:

· Patients who require corticosteroids for other diseases

· History of prior malignancies within the last 5 years (except for surgically-cured non-melanoma skin cancer, or cervical carcinoma in situ)

· Prior chemotherapy or radiation within the last five years

· Normal chemistry and hematology

**Referral to UCLA study site prior to planned nephrectomy is recommended in order to initiate protocol process, informed consent and to schedule post-op staging Cat Scans at UCLA Medical Center. Please note the nephrectomy does not need to be performed at UCLA. Kidney Cancer Program contact information is listed below.

For More Information

For additional information on inclusion and exclusion criteria and whether or not you may be a candidate to participate in a trial, call Nazy Zomorodian, Director for the Clinical Trials Office at (310) 794-7704.