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Sponsored by: |
Antigenics |
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Information provided by: | Antigenics |
ClinicalTrials.gov Identifier: | NCT00033904 |
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.
Condition | Intervention | Phase |
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Renal Cell Carcinoma |
Drug: autologous human tumor-derived HSPPC-96 |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 650 |
Study Start Date: | June 2000 |
Primary Objective:
Secondary Objective:
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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:
Study ID Numbers: | C-100-12 Part I |
Study First Received: | April 12, 2002 |
Last Updated: | July 11, 2007 |
ClinicalTrials.gov Identifier: | NCT00033904 |
Health Authority: | United States: Food and Drug Administration |
Kidney Cancer, renal, immunotherapy, tumor, |
Urogenital Neoplasms Renal cancer Urologic Neoplasms Kidney cancer Recurrence Carcinoma Urologic Diseases |
Kidney Neoplasms Carcinoma, Renal Cell Kidney Diseases Adenocarcinoma Urinary tract neoplasm Neoplasms, Glandular and Epithelial |
Neoplasms Neoplasms by Site Neoplasms by Histologic Type |