Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Treatment Completed 18 and over Pharmaceutical / Industry C-100-21 NCT00039000

Trial Description

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.

Further Study Information

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.

Trial Contact Information

Trial Lead Organizations/Sponsors

Antigenics, Incorporated

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00039000
Information obtained from ClinicalTrials.gov on May 27, 2008