- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00082459
Trial to Compare the Routes of Administration of an Investigational, Personalized, Therapeutic Cancer Vaccine Oncophage (HSPPC-96) in Patients With Metastatic Renal Cell Carcinoma
September 6, 2012 updated by: Agenus Inc.
A Randomized Phase II Study Investigating the Route of Administration of Oncophage (HSPPC-96) in Patients With Metastatic Renal Cell Carcinoma
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
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
Enrollment
40
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Texas
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Houston, Texas, United States
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2002
Primary Completion (Actual)
December 1, 2005
Study Completion (Actual)
December 1, 2005
Study Registration Dates
First Submitted
May 10, 2004
First Submitted That Met QC Criteria
May 11, 2004
First Posted (Estimate)
May 12, 2004
Study Record Updates
Last Update Posted (Estimate)
September 7, 2012
Last Update Submitted That Met QC Criteria
September 6, 2012
Last Verified
September 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- C-100-23
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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