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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Agenus, Inc.
ClinicalTrials.gov Identifier:
NCT00039000
First received: June 6, 2002
Last updated: September 6, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention Phase
Malignant Melanoma
Drug: HSPPC-96 or Oncophage
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Agenus, Inc.:

Estimated Enrollment: 350
Study Start Date: March 2002
Study Completion Date: December 2005
Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00039000

  Show 77 Study Locations
Sponsors and Collaborators
Agenus, Inc.
  More Information

Additional Information:
No publications provided

Responsible Party: Agenus, Inc.
ClinicalTrials.gov Identifier: NCT00039000     History of Changes
Obsolete Identifiers: NCT00047359
Other Study ID Numbers: C-100-21
Study First Received: June 6, 2002
Last Updated: September 6, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Agenus, Inc.:
Immunotherapy, Cancer, Melanoma, Skin Cancer, tumor

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas

ClinicalTrials.gov processed this record on April 15, 2014