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Sponsored by: |
Antigenics |
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Information provided by: | Antigenics |
ClinicalTrials.gov Identifier: | NCT00082459 |
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 |
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Renal Cell Carcinoma |
Biological: autologous human tumor-derived HSPPC-96 |
Phase II |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | C-100-23 |
Study First Received: | May 10, 2004 |
Last Updated: | March 7, 2006 |
ClinicalTrials.gov Identifier: | NCT00082459 |
Health Authority: | United States: Food and Drug Administration |
Kidney Cancer Renal Tumor Immunotherapy |
Urologic Diseases Kidney Neoplasms Carcinoma, Renal Cell Urogenital Neoplasms Renal cancer Kidney Diseases |
Kidney cancer Urologic Neoplasms Adenocarcinoma Urinary tract neoplasm Neoplasms, Glandular and Epithelial Carcinoma |
Neoplasms Neoplasms by Site Neoplasms by Histologic Type |