Trial to Compare the Routes of Administration of an Investigational, Personalized, Therapeutic Cancer Vaccine Oncophage (HSPPC-96) in Patients With Metastatic Renal Cell Carcinoma

This study has been terminated.
(Lack of enrollment)
Sponsor:
Information provided by (Responsible Party):
Agenus, Inc.
ClinicalTrials.gov Identifier:
NCT00082459
First received: May 10, 2004
Last updated: September 6, 2012
Last verified: September 2012
  Purpose

The goal of this trial is to determine the safety of HSPPC-96 and which route of administration achieves a better response with the vaccine. HSPPC-96 is an immunotherapeutic agent made from an individual patient's tumor.


Condition Intervention Phase
Renal Cell Carcinoma
Biological: autologous human tumor-derived HSPPC-96
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Phase II Study Investigating the Route of Administration of Oncophage (HSPPC-96) in Patients With Metastatic Renal Cell Carcinoma

Resource links provided by NLM:


Further study details as provided by Agenus, Inc.:

Estimated Enrollment: 40
Study Start Date: July 2002
Study Completion Date: December 2005
Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)
Detailed Description:

The goal of this trial is to determine the safety of HSPPC-96 and which route of administration achieves a better response with the vaccine. HSPPC-96 is an immunotherapeutic agent made from an individual patient's tumor. The study is being conducted in Houston, Texas with patients enrolled into one of two treatment arms. The two treatment arms are either subcutaneous injection or intradermal injection, both with HSPPC-96. To be treated with HSPPC-96 patients must undergo surgery to remove the kidney tumor and a portion of this tissue will be sent to Antigenics' manufacturing facility for processing.

  Eligibility

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

Inclusion Criteria:

  • Suspected metastatic renal cell carcinoma (AJCC Stage IV) with intact primary tumor
  • No previous therapy for metastatic renal cell carcinoma
  • Measurable disease (RECIST criteria)
  • Primary tumor greater than or equal to 7cm on CT or MRI
  • ECOG performance status 0-1
  • At least 18 years old
  • Life expectancy > 3 months
  • Adequate cardiac function (NYHA I-II)
  • Not pregnant
  • Provide written informed consent
  • Absence of multiple liver metastases, brain or threatening bone metastases (axial skeleton and/or pathological features)
  • Planned complete nephrectomy

Exclusion Criteria:

  • History of primary or secondary immunodeficiency, or patients using systemic corticosteroids or cyclosporin A
  • Other cancer (including renal cell carcinoma) within the last five years (with the exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri or basal or squamous cell carcinoma of the skin)
  • Embolization of the renal artery prior to nephrectomy
  • Active, uncontrolled infection or other serious medical illnesses, preventing study completion, in the opinion of the Principal Investigator
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00082459

Locations
United States, Texas
Houston, Texas, United States
Sponsors and Collaborators
Agenus, Inc.
  More Information

Additional Information:
No publications provided

Responsible Party: Agenus, Inc.
ClinicalTrials.gov Identifier: NCT00082459     History of Changes
Other Study ID Numbers: C-100-23
Study First Received: May 10, 2004
Last Updated: September 6, 2012
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on July 28, 2014