Study of Heat Shock Protein-Peptide Complex (HSPPC-96) Versus IL-2/DTIC for Stage IV Melanoma
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
1 other identifier
interventional
350
9 countries
77
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Mar 2002
Typical duration for phase_3
77 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2002
CompletedFirst Submitted
Initial submission to the registry
June 6, 2002
CompletedFirst Posted
Study publicly available on registry
June 10, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2005
CompletedSeptember 7, 2012
September 1, 2012
3.8 years
June 6, 2002
September 6, 2012
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Stage IV Melanoma (AJCC);
- No prior therapy for stage IV melanoma;
- No prior therapy with interleukin-2 and/or dacarbazine/temozolomide within the past 12 months prior to study entry;
- Candidate for surgical resection of some/all sites of melanoma and expected to obtain greater tan or equal to 7 grams of viable cancer tissue (in aggregate), which is equivalent to a greater than or equal to 2 cm lesion on CT/MRI or clinical examination;
- No brain metastases;
- ECOG score 0 or 1;
- Adequate cardiac function;
- Adequate hematopoietic, liver and renal function;
- Female subjects of child-bearing potential must agree to use contraception during the study
- Signed written informed consent.
You may not qualify if:
- Mucosal or ocular melanomas;
- Other malignancies treated within the last five years, except in situ cervix carcinoma or non-melanoma skin cancer;
- Primary or secondary immunodeficiency, in the opinion of the investigator (including immunosuppressive disease, or use of systemic corticosteroids or other immunosuppressive medications);
- Prior splenectomy;
- Uncontrolled infection or other serious medical illnesses;
- Women who are pregnant or breast-feeding;
- Subjects participating in any other studies requiring administration of an investigational drug/biologic agent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Agenus Inc.lead
Study Sites (77)
Unknown Facility
Birmingham, Alabama, United States
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Scottsdale, Arizona, United States
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Berkeley, California, United States
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Los Angeles, California, United States
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Stanford, California, United States
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Vista, California, United States
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Denver, Colorado, United States
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Farmington, Connecticut, United States
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Jacksonville, Florida, United States
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Lakeland, Florida, United States
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Miami Beach, Florida, United States
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Atlanta, Georgia, United States
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Chicago, Illinois, United States
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Park Ridge, Illinois, United States
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Kansas City, Kansas, United States
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Louisville, Kentucky, United States
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Baltimore, Maryland, United States
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Boston, Massachusetts, United States
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Robbinsdale, Minnesota, United States
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Rochester, Minnesota, United States
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Columbia, Missouri, United States
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St Louis, Missouri, United States
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Lebanon, New Hampshire, United States
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New Brunswick, New Jersey, United States
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New York, New York, United States
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Cincinnati, Ohio, United States
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Cleveland, Ohio, United States
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Tulsa, Oklahoma, United States
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Portland, Oregon, United States
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Philadelphia, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Knoxville, Tennessee, United States
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Dallas, Texas, United States
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Houston, Texas, United States
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Madison, Wisconsin, United States
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Adelaide, Australia
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Camperdown, Australia
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Melbourne, Australia
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Newcastle, Australia
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Wentworthville, Australia
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Budapest, Hungary
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Debrecen, Hungary
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Pécs, Hungary
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Szeged, Hungary
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Aviano, Italy
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Genova, Italy
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Milan, Italy
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Rimini, Italy
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Bialystock, Poland
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Bydgoszcz, Poland
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Krakow, Poland
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Arkhangelsk, Russia
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Chelyabinsk, Russia
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Kazan', Russia
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Krasnodar, Russia
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Moscow, Russia
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Novosibirsk, Russia
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Ryazan, Russia
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Saint Petersburg, Russia
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Samara, Russia
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Stavropol, Russia
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Voronezh, Russia
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Gothenburg, Sweden
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Lund, Sweden
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Vaxjo, Sweden
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Dnipro, Ukraine
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Donetsk, Ukraine
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Ivano-Frankivsk, Ukraine
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Kiev, Ukraine
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Kryvyi Rih, Ukraine
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Lviv, Ukraine
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Odesa, Ukraine
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Uzhhorod, Ukraine
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Vinnitsa, Ukraine
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Leeds, United Kingdom
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London, United Kingdom
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Manchester, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 6, 2002
First Posted
June 10, 2002
Study Start
March 1, 2002
Primary Completion
December 1, 2005
Study Completion
December 1, 2005
Last Updated
September 7, 2012
Record last verified: 2012-09