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

September 6, 2012 updated by: Agenus Inc.

A Multi-Center, Randomized, Phase 3 Study of Adjuvant Oncophage® Versus Observation in Patients With High Risk After Surgical Treatment for Renal Cell Carcinoma

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Biological: HSPPC-96

Detailed Description

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.

Study Type

Interventional

Enrollment

600

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

This does not represent the full set of inclusion/exclusion criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Factorial Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
To determine whether patients randomized to receive adjuvant HSPPC-96 (treatment) after surgical resection of the kidney cancer have improved recurrence-free survival as compared to patients who did not receive adjuvant treatment (observation)

Secondary Outcome Measures

Outcome Measure
To determine whether patients randomized to receive adjuvant HSPPC-96 have improved overall survival as compared to patients in the observation group (without adjuvant treatment)
To further characterize the safety profile of HSPPC-96

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Agenus Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2005

Primary Completion (Actual)

March 1, 2006

Study Completion (Actual)

March 1, 2006

Study Registration Dates

First Submitted

August 2, 2005

First Submitted That Met QC Criteria

August 2, 2005

First Posted (Estimate)

August 3, 2005

Study Record Updates

Last Update Posted (Estimate)

September 7, 2012

Last Update Submitted That Met QC Criteria

September 6, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

C-100-12 Part 2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.