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

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ClinicalTrials.gov Identifier: NCT00082459
Recruitment Status : Terminated (Lack of enrollment)
First Posted : May 12, 2004
Last Update Posted : September 7, 2012
Sponsor:
Information provided by (Responsible Party):
Agenus Inc.

Brief Summary:
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 or disease Intervention/treatment Phase
Renal Cell Carcinoma Biological: autologous human tumor-derived HSPPC-96 Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : July 2002
Actual Primary Completion Date : December 2005
Actual Study Completion Date : December 2005

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00082459


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

Responsible Party: Agenus Inc.
ClinicalTrials.gov Identifier: NCT00082459     History of Changes
Other Study ID Numbers: C-100-23
First Posted: May 12, 2004    Key Record Dates
Last Update Posted: September 7, 2012
Last Verified: September 2012

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