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

September 6, 2012 updated by: Agenus Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

350

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Adelaide, Australia
      • Camperdown, Australia
      • Melbourne, Australia
      • Newcastle, Australia
      • Wentworthville, Australia
  • Hungary
      • Budapest, Hungary
      • Debrecen, Hungary
      • Pecs, Hungary
      • Szeged, Hungary
  • Italy
      • Aviano, Italy
      • Genova, Italy
      • Milan, Italy
      • Rimini, Italy
  • Poland
      • Bialystock, Poland
      • Bydgoszcz, Poland
      • Krakow, Poland
  • Russian Federation
      • Arkhangelsk, Russian Federation
      • Chelyabinsk, Russian Federation
      • Kazan, Russian Federation
      • Krasnodar, Russian Federation
      • Moscow, Russian Federation
      • Novosibirsk, Russian Federation
      • Ryazan, Russian Federation
      • Samara, Russian Federation
      • St. Petersburg, Russian Federation
      • Stavropol, Russian Federation
      • Voronezh, Russian Federation
  • Sweden
      • Gothenburg, Sweden
      • Lund, Sweden
      • Vaxjo, Sweden
  • Ukraine
      • Dnepropetrovsk, Ukraine
      • Donetsk, Ukraine
      • Ivano-Frankovsk, Ukraine
      • Kiev, Ukraine
      • Krivoy Rog, Ukraine
      • Lviv, Ukraine
      • Odessa, Ukraine
      • Uzhgorod, Ukraine
      • Vinnitsa, Ukraine
  • United Kingdom
      • Leeds, United Kingdom
      • London, United Kingdom
      • Manchester, United Kingdom
  • United States
    • Alabama
      • Birmingham, Alabama, United States
    • Arizona
      • Scottsdale, Arizona, United States
    • California
      • Berkeley, California, United States
      • Los Angeles, California, United States
      • Stanford, California, United States
      • Vista, California, United States
    • Colorado
      • Denver, Colorado, United States
    • Connecticut
      • Farmington, Connecticut, United States
    • Florida
      • Jacksonville, Florida, United States
      • Lakeland, Florida, United States
      • Miami Beach, Florida, United States
    • Georgia
      • Atlanta, Georgia, United States
    • Illinois
      • Chicago, Illinois, United States
      • Park Ridge, Illinois, United States
    • Kansas
      • Kansas City, Kansas, United States
    • Kentucky
      • Louisville, Kentucky, United States
    • Maryland
      • Baltimore, Maryland, United States
    • Massachusetts
      • Boston, Massachusetts, United States
    • Minnesota
      • Robbinsdale, Minnesota, United States
      • Rochester, Minnesota, United States
    • Missouri
      • Columbia, Missouri, United States
      • St. Louis, Missouri, United States
    • New Hampshire
      • Lebanon, New Hampshire, United States
    • New Jersey
      • New Brunswick, New Jersey, United States
    • New York
      • New York City, New York, United States
    • Ohio
      • Cincinnati, Ohio, United States
      • Cleveland, Ohio, United States
    • Oklahoma
      • Tulsa, Oklahoma, United States
    • Oregon
      • Portland, Oregon, United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States
      • Pittsburgh, Pennsylvania, United States
    • Tennessee
      • Knoxville, Tennessee, United States
    • Texas
      • Dallas, Texas, United States
      • Houston, Texas, United States
    • Wisconsin
      • Madison, Wisconsin, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Agenus Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2002

Primary Completion (Actual)

December 1, 2005

Study Completion (Actual)

December 1, 2005

Study Registration Dates

First Submitted

June 6, 2002

First Submitted That Met QC Criteria

June 7, 2002

First Posted (Estimate)

June 10, 2002

Study Record Updates

Last Update Posted (Estimate)

September 7, 2012

Last Update Submitted That Met QC Criteria

September 6, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C-100-21

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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