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

Last updated: September 6, 2012
Sponsor: Agenus Inc.
Overall Status: Terminated

Phase

3

Condition

Renal Cell Carcinoma

Carcinoma

Urothelial Tract Cancer

Treatment

N/A

Clinical Study ID

NCT00126178
C-100-12 Part 2
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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

  • Patients must have primary-intact resectable renal cell cancer, without distantmetastasis 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

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 adequatelytreated cone-biopsied in situ carcinoma of the cervix uteri, basal or squamous cellcarcinoma 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 Design

Total Participants: 600
Study Start date:
May 01, 2005
Estimated Completion Date:
March 31, 2006

Study 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.

Connect with a study center

  • Victoria, British Columbia
    Canada

    Site Not Available

  • Toronto, Ontario
    Canada

    Site Not Available

  • San Francisco, California
    United States

    Site Not Available

  • Stanford, California
    United States

    Site Not Available

  • Hackensack, New Jersey
    United States

    Site Not Available

  • San Antonio, Texas
    United States

    Site Not Available

  • South Burlington, Vermont
    United States

    Site Not Available

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