This is an international, open label, randomized Phase 3 trial in which patients with surgically removable kidney cancer will be randomly selected post-operatively to receive adjuvant treatment with HSPPC-96 or no adjuvant treatment. All patients will undergo complete surgical removal of their tumors.~The primary objective of the study is to determine whether patients who receive adjuvant autologous HSPPC-96 (treatment group) after surgical resection of locally advanced renal cell carcinoma have improved recurrence-free survival as compared to patients who are not receiving adjuvant treatment (observation group). Eligible patients will have a 50% chance of receiving adjuvant treatment with HSPPC-96. Patients in the treatment arm of the trial will receive the vaccine once a week for 4 weeks, and then every other week until vaccine depletion or disease recurrence. Both groups of patients will be followed regularly for assessment of their disease status.~HSPPC-96 is an investigational, immunotherapeutic agent made from an individual patient's own tumor, which is collected at the time of surgery. A portion of the tumor tissue is sent to Antigenics' manufacturing facility where it will undergo processing to create a vaccine.
This is an international, open label, randomized phase 3 trial in which patients with surgically removable kidney cancer will be randomly selected post-operatively to receive adjuvant treatment with autologous HSPPC-96 or no adjuvant treatment. All patients will undergo complete surgical removal of their tumors.