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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Agenus, Inc.
ClinicalTrials.gov Identifier:
NCT00126178
First received: August 2, 2005
Last updated: September 6, 2012
Last verified: September 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Kidney Cancer
Renal Cell Carcinoma
 Biological: HSPPC-96
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multi-Center, Randomized, Phase 3 Study of Adjuvant Oncophage® Versus Observation in Patients With High Risk After Surgical Treatment for Renal Cell Carcinoma

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Agenus, Inc.:

Primary Outcome Measures:
  • 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:
  • 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

Estimated Enrollment: 600
Study Start Date: May 2005
Study Completion Date: March 2006
Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00126178

Locations
United States, California
San Francisco, California, United States
Stanford, California, United States
United States, New Jersey
Hackensack, New Jersey, United States
United States, Texas
San Antonio, Texas, United States
United States, Vermont
South Burlington, Vermont, United States
Canada, British Columbia
Victoria, British Columbia, Canada
Canada, Ontario
Toronto, Ontario, Canada
Sponsors and Collaborators
Agenus, Inc.
  More Information

Additional Information:
For more information on Antigenics and HSPPC-96, please visit our company website  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Agenus, Inc.
ClinicalTrials.gov Identifier: NCT00126178     History of Changes
Other Study ID Numbers: C-100-12 Part 2
Study First Received: August 2, 2005
Last Updated: September 6, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Agenus, Inc.:
Kidney Cancer
Renal
Immunotherapy
Vaccine

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Renal Cell
Kidney Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
 Adenocarcinoma
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on May 21, 2013