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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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Neuroectodermal Tumors
Neuroendocrine Tumors
Nevi and Melanomas

ClinicalTrials.gov processed this record on November 25, 2014