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Sponsored by: |
Antigenics |
---|---|
Information provided by: | Antigenics |
ClinicalTrials.gov Identifier: | NCT00039000 |
The primary goal of this study is to determine if people with metastatic melanoma who receive Heat Shock Protein-Peptide Complex - 96 (HSPPC-96 or Oncophage) after surgery live longer than people who may or may not have surgery but who receive conventional chemotherapy including IL-2/DTIC. A second goal is to determine the safety and frequency of side effects in subjects who receive therapy with HSPPC-96.
Condition | Intervention | Phase |
---|---|---|
Malignant Melanoma |
Drug: HSPPC-96 or Oncophage |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase III Study of Heat Shock Protein-Peptide Complex (HSPPC-96) Versus Physician's Choice Including Interleukin-2 and/or Dacarbazine/Temozolomide-Based Therapy and/or Complete Tumor Resection in Stage IV Melanoma |
Estimated Enrollment: | 350 |
Study Start Date: | March 2002 |
Primary Objective:
Secondary Objective:
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Eligibility Assessment:
(The following assessments must be obtained within three weeks prior to randomization into the study)
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | C-100-21 |
Study First Received: | June 6, 2002 |
Last Updated: | July 11, 2007 |
ClinicalTrials.gov Identifier: | NCT00039000 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Immunotherapy, Cancer, Melanoma, Skin Cancer, tumor |
Neuroectodermal Tumors Dacarbazine Shock Interleukin-2 Nevus, Pigmented Neoplasms, Germ Cell and Embryonal |
Neuroepithelioma Nevus Skin Neoplasms Temozolomide Neuroendocrine Tumors Melanoma |
Neuroectodermal Tumors Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal |
Neoplasms, Nerve Tissue Nevi and Melanomas Neuroendocrine Tumors Melanoma |