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

Study Overview
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Brief Summary
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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
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Primary Objective: 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.

Official Title
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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

Conditions
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Malignant Melanoma

Intervention / Treatment
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* Drug: HSPPC-96 or Oncophage


Participation Criteria
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Eligibility Criteria
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Eligibility Assessment: (The following assessments must be obtained within three weeks prior to randomization into the study) Medical history and physical examination (including EGOG score, evidence of immunosuppression); CT/MRI of the chest, abdomen and pelvis; Clinical examination; CT/MRI of the brain; Complete Blood Count with differential including platelets; Electrolytes (Na, Cl, K, HCO3, Ca, Mg, PO4); Renal function tests (BUN and creatinine); Liver function tests (bilirubin, AST, ALT); Serum pregnancy test for all women of childbearing potential. Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: HSPPC-96 or Oncophage|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Immunotherapy, Cancer, Melanoma, Skin Cancer, tumor