Study of Heat Shock Protein-Peptide Complex (HSPPC-96) Versus IL-2/DTIC for Stage IV Melanoma

Completed · Phase 3

Conditions studied: Malignant Melanoma

In brief

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.

Key facts

Study ID

NCT00039000

Run by

Agenus Inc.

People needed

350

Starts

2002-03-01

Expected to finish

2005-12-01

Last updated by the study team

2012-09-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Study site — Scottsdale, Arizona, United States
• Study site — Berkeley, California, United States
• Study site — Los Angeles, California, United States
• Study site — Stanford, California, United States
• Study site — Vista, California, United States
• Study site — Denver, Colorado, United States
• Study site — Farmington, Connecticut, United States
• Study site — Jacksonville, Florida, United States
• Study site — Lakeland, Florida, United States
• Study site — Miami Beach, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Chicago, Illinois, United States
• Study site — Park Ridge, Illinois, United States
• Study site — Kansas City, Kansas, United States
• Study site — Louisville, Kentucky, United States
• Study site — Baltimore, Maryland, United States
• Study site — Boston, Massachusetts, United States
• Study site — Robbinsdale, Minnesota, United States
• Study site — Rochester, Minnesota, United States
• Study site — Columbia, Missouri, United States
• Study site — St Louis, Missouri, United States
• Study site — Lebanon, New Hampshire, United States
• Study site — New Brunswick, New Jersey, United States
• Study site — New York, New York, United States
• Study site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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