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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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.

Tracking Information
First Submitted Date  ICMJE May 10, 2004
First Posted Date  ICMJE May 12, 2004
Last Update Posted Date September 7, 2012
Study Start Date  ICMJE July 2002
Actual Primary Completion Date December 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Trial to Compare the Routes of Administration of an Investigational, Personalized, Therapeutic Cancer Vaccine Oncophage (HSPPC-96) in Patients With Metastatic Renal Cell Carcinoma
Official Title  ICMJE A Randomized Phase II Study Investigating the Route of Administration of Oncophage (HSPPC-96) in Patients With Metastatic Renal Cell Carcinoma
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Renal Cell Carcinoma
Intervention  ICMJE Biological: autologous human tumor-derived HSPPC-96
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Enrollment  ICMJE
 (submitted: June¬†23,¬†2005)
40
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2005
Actual Primary Completion Date December 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00082459
Other Study ID Numbers  ICMJE C-100-23
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Agenus Inc.
Study Sponsor  ICMJE Agenus Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Agenus Inc.
Verification Date September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP