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| Sponsored by: |
Antigenics |
| Information provided by: | Antigenics |
| ClinicalTrials.gov Identifier: | NCT00082459 |
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 II |
| MedlinePlus related topics: | Cancer |
| Drug Information available for: | Oncophage |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | A Randomized Phase II Study Investigating the Route of Administration of Oncophage (HSPPC-96) in Patients With Metastatic Renal Cell Carcinoma |
| Estimated Enrollment: | 40 |
| Study Start Date: | July 2002 |
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
Click here for more information regarding HSPPC-96 at Antigenics' website. 
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| Study ID Numbers: | C-100-23 |
| First Received: | May 10, 2004 |
| Last Updated: | March 7, 2006 |
| ClinicalTrials.gov Identifier: | NCT00082459 |
| Health Authority: | United States: Food and Drug Administration |
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