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| Descriptive Information Fields | |
| Brief Title † | Survival Study Of Oncophage® vs. Observation In Patients With Kidney Cancer |
| Official Title † | A Multi-Center, Randomized Phase III Study of Adjuvant Oncophage® Versus Observation in Subjects With High Risk of Recurrence After Surgical Treatment for Renal Cell Carcinoma |
| Brief Summary | Determine whether patients receiving adjuvant HSPPC-96 treatment after surgically resected, locally advanced renal cell carcinoma have improved recurrence-free survival as compared to subjects with no adjuvant treatment. |
| Detailed Description | Primary Objective:
Secondary Objective:
|
| Study Phase | Phase III |
| Study Type † | Interventional |
| Study Design † | Treatment, Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Primary Outcome Measure † | |
| Secondary Outcome Measure † | |
| Condition † | Renal Cell Carcinoma |
| Intervention † | Drug: autologous human tumor-derived HSPPC-96 |
| MEDLINE PMIDs | |
| Links | Click here for more information about Oncophage (HSPPC-96) ![]() |
| Recruitment Information Fields | |
| Recruitment Status † | Completed |
| Enrollment † | 650 |
| Start Date † | June 2000 |
| Completion Date | |
| Eligibility Criteria † | Pre-Surgery Inclusion Criteria:
Pre-Surgery Exclusion Criteria:
Eligibility Assessment: (between 2 weeks pre- and 4 weeks post-surgery) Prior to randomization and entry into the tumor evaluation phase, all subjects must undergo testing to confirm that they are free of distant metastatic disease, and that they meet all other criteria. Eligibility Criteria which must be assessed and confirmed prior to randomization:
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| Gender | Both |
| Ages | 18 Years and older |
| Accepts Healthy Volunteers | No |
| Contacts †† | |
| Location Countries † | United States, Austria, Belgium, Canada, France, Israel, Norway, Poland, Spain, Sweden, United Kingdom |
| Administrative Information Fields | |
| NCT ID † | NCT00033904 |
| Organization ID | C-100-12 Part I |
| Secondary IDs †† | |
| Study Sponsor † | Antigenics |
| Collaborators †† | |
| Investigators † | |
| Information Provided By | Antigenics |
| Verification Date | July 2007 |
| First Received Date † | April 12, 2002 |
| Last Updated Date | July 11, 2007 |