Study of Heat Shock Protein-Peptide Complex (HSPPC-96) Versus IL-2/DTIC for Stage IV Melanoma
NCT ID: NCT00039000
Last Updated: 2012-09-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
350 participants
INTERVENTIONAL
2002-03-31
2005-12-31
Brief Summary
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Detailed Description
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* To determine whether subjects with stage IV melanoma randomized to HSPPC-96 have longer survival than subjects randomized to physician's choice including interleukin-2 and/or dacarbazine/temozolomide and/or complete tumor resection.
Secondary Objective:
* To determine frequency of adverse events in subjects randomized to HSPPC-96.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Interventions
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HSPPC-96 or Oncophage
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Agenus Inc.
INDUSTRY
Responsible Party
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Locations
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Birmingham, Alabama, United States
Scottsdale, Arizona, United States
Berkeley, California, United States
Los Angeles, California, United States
Stanford, California, United States
Vista, California, United States
Denver, Colorado, United States
Farmington, Connecticut, United States
Jacksonville, Florida, United States
Lakeland, Florida, United States
Miami Beach, Florida, United States
Atlanta, Georgia, United States
Chicago, Illinois, United States
Park Ridge, Illinois, United States
Kansas City, Kansas, United States
Louisville, Kentucky, United States
Baltimore, Maryland, United States
Boston, Massachusetts, United States
Robbinsdale, Minnesota, United States
Rochester, Minnesota, United States
Columbia, Missouri, United States
St Louis, Missouri, United States
Lebanon, New Hampshire, United States
New Brunswick, New Jersey, United States
New York, New York, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Tulsa, Oklahoma, United States
Portland, Oregon, United States
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Knoxville, Tennessee, United States
Dallas, Texas, United States
Houston, Texas, United States
Madison, Wisconsin, United States
Adelaide, , Australia
Camperdown, , Australia
Melbourne, , Australia
Newcastle, , Australia
Wentworthville, , Australia
Budapest, , Hungary
Debrecen, , Hungary
Pécs, , Hungary
Szeged, , Hungary
Aviano, , Italy
Genova, , Italy
Milan, , Italy
Rimini, , Italy
Bialystock, , Poland
Bydgoszcz, , Poland
Krakow, , Poland
Arkhangelsk, , Russia
Chelyabinsk, , Russia
Kazan', , Russia
Krasnodar, , Russia
Moscow, , Russia
Novosibirsk, , Russia
Ryazan, , Russia
Saint Petersburg, , Russia
Samara, , Russia
Stavropol, , Russia
Voronezh, , Russia
Gothenburg, , Sweden
Lund, , Sweden
Vaxjo, , Sweden
Dnipro, , Ukraine
Donetsk, , Ukraine
Ivano-Frankivsk, , Ukraine
Kiev, , Ukraine
Kryvyi Rih, , Ukraine
Lviv, , Ukraine
Odesa, , Ukraine
Uzhhorod, , Ukraine
Vinnitsa, , Ukraine
Leeds, , United Kingdom
London, , United Kingdom
Manchester, , United Kingdom
Countries
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Other Identifiers
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C-100-21
Identifier Type: -
Identifier Source: org_study_id
NCT00047359
Identifier Type: -
Identifier Source: nct_alias