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Tracking Information | |
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First Received Date † | June 6, 2002 |
Last Updated Date | July 11, 2007 |
Start Date † | March 2002 |
Current Primary Outcome Measures † | |
Original Primary Outcome Measures † | |
Change History | Complete list of historical versions of study NCT00039000 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures † | |
Original Secondary Outcome Measures † | |
Descriptive Information | |
Brief Title † | Study of Heat Shock Protein-Peptide Complex (HSPPC-96) Versus IL-2/DTIC for Stage IV Melanoma |
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 |
Brief Summary | 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. |
Detailed Description | Primary Objective:
Secondary Objective:
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Study Phase | Phase III |
Study Type † | Interventional |
Study Design † | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Condition † | Malignant Melanoma |
Intervention † | Drug: HSPPC-96 or Oncophage |
Study Arms / Comparison Groups | |
Publications * | |
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |
Recruitment Status † | Completed |
Enrollment † | 350 |
Completion Date | |
Primary Completion Date | |
Eligibility Criteria † | Eligibility Assessment: (The following assessments must be obtained within three weeks prior to randomization into the study)
Inclusion Criteria:
Exclusion Criteria:
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Gender | Both |
Ages | 18 Years and older |
Accepts Healthy Volunteers | No |
Contacts †† | |
Location Countries † | United States, Australia, Hungary, Italy, Poland, Russian Federation, Sweden, Ukraine, United Kingdom |
Expanded Access Status | |
Administrative Information | |
NCT ID † | NCT00039000 |
Responsible Party | |
Secondary IDs †† | |
Study Sponsor † | Antigenics |
Collaborators †† | |
Investigators † | |
Information Provided By | Antigenics |
Verification Date | July 2007 |
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |