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

Malignant Melanoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00039000
• Other study ID #: C-100-21
• Status: Completed
• Phase: Phase 3
• First received: June 6, 2002
• Last updated: September 6, 2012
• Start date: March 2002
• Est. completion date: December 2005

Study information

• Verified date: September 2012
• Source: Agenus, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT00047359

Recruitment information / eligibility

• Status: Completed
• Enrollment: 350
• Est. completion date: December 2005
• Est. primary completion date: December 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Malignant Melanoma
• Melanoma

Intervention

Drug:
• HSPPC-96 or Oncophage

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Agenus, Inc.

Countries where clinical trial is conducted

United States,  Australia,  Hungary,  Italy,  Poland,  Russian Federation,  Sweden,  Ukraine,  United Kingdom,