Clinical Trial Studying a Personalized Cancer Vaccine in Patients With Non-metastatic Kidney Cancer

Stopped early · Phase 3

Conditions studied: Kidney Cancer, Renal Cell Carcinoma

In brief

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.

Key facts

Study ID

NCT00126178

Run by

Agenus Inc.

People needed

600

Starts

2005-05-01

Expected to finish

2006-03-01

Last updated by the study team

2012-09-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients must have primary-intact resectable renal cell cancer, without distant metastasis and be scheduled to have surgery with curative intent
• Tumor size > 5 cm OR macroscopic nodes OR vena cava thrombus by radiologic evaluation
• At least 18 years old
• Signed informed consent

You may not qualify if…

• Prior surgery, chemo-, hormonal-, immuno-, or radiotherapy for kidney cancer
• History of other cancers within the last five years, with the exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri, basal or squamous cell carcinoma of the skin
• Current malignancies of any type in other sites
• No active uncontrolled infection, other serious medical illnesses, or splenectomy
• History of primary or secondary immunodeficiencies

Where it is running

• Study site — San Francisco, California, United States
• Study site — Stanford, California, United States
• Study site — Hackensack, New Jersey, United States
• Study site — San Antonio, Texas, United States
• Study site — South Burlington, Vermont, United States
• Study site — Victoria, British Columbia, Canada
• Study site — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.