Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Houston, Texas


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.


Study 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. 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.


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


NCT ID:

NCT00082459


Primary Contact:

N/A


Backup Contact:

N/A


Location Contact:

Houston, Texas
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 15, 2017

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

This study is not currently recruiting Study Participants on ClinicalConnection.com. The form below is not enabled.