Clinical trial NCT00039000: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Malignant Melanoma
Keywords: Immunotherapy, Cancer, Melanoma, Skin Cancer, tumor
Lead sponsor: Agenus Inc.
Sponsor class: INDUSTRY
First posted: 2002-06-10
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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:

* 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.

Eligibility criteria: 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
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country: Russian Federation
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country: Russian Federation
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country: Russian Federation
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country: Russian Federation
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country: Sweden
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country: Sweden
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country: Sweden
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country: Ukraine
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city: Vinnitsa
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city: London
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city: Manchester
country: United Kingdom
Study officials:
References: