Kidney Cancer - Wilex cG250 - A Randomized Phase III Study for patients with Kidney Cancer

	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 - Wilex cG250 - A Randomized Phase III Study for patients with Kidney Cancer

Principal Investigator:	Arie Belldegrun, MD

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

Objective

STUDY TITLE: WILEX cG250 - 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

STUDY PURPOSE: The purpose of this study is to determine the safety and effectiveness of an experimental therapy, the antibody cG250, in preventing the return of your tumor. To find out the effectiveness of this antibody therapy, you will be placed in one of two treatment groups. Half of the subjects in this trial will receive the antibody cG250 therapy and the other half will receive placebo. A placebo is a pill that looks identical to the study medication but does not contain the cG250 antibody. Your assignment to cG250 or placebo is based on chance in a process similar to drawing cards, rather than a medical decision made by the study doctor. Neither you nor your study doctor will know which treatment you will get; however, in an emergency, your study doctor will be able to find out which medication you are receiving.

Patient Eligibility

INCLUSION CRITERIA:

Prior (partial or total) nephrectomy of primary renal cell carcinoma with documented clear cell histology
Adenectomy of regional lymph nodes and staging is required.
No evidence of macroscopic and microscopic residual disease.
Patients diagnosed of having one of the following:
– WBC < 3.0 x 10^8/dl

– Platelet count < 100 x 108/dl

– Hemoglobin < 6.2 mmol/l

– Total bilirubin < 1.5 x ULN, ASAT, A L AT < 3 x ULN, Serum creatinine < 2 x ULN
Not more than 6 weeks after nephrectomy.

EXCLUSION CRITERIA:

Pre-exposure to murine/chimeric antibody therapy.
Patients who require or are likely to require corticosteriods for another disease (patients on physiologic corticosteroid replacement therapy may be included in the study at the discretion of PI).
Prior organ transplantation.
History of prior malignancies within the last 5 years, except for surgically-cured non-melanoma skin cancer, or cervical carcinoma in situ.
Prior radiation or chemotherapy within the last 5 years.

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, at (310) 794-7704.