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Trial record 62 of 519 for:    melanoma phase III

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00039000
Recruitment Status : Completed
First Posted : June 10, 2002
Last Update Posted : September 7, 2012
Information provided by (Responsible Party):
Agenus Inc.

Brief 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.

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

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 350 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : March 2002
Actual Primary Completion Date : December 2005
Actual Study Completion Date : December 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma Shock

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00039000

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Sponsors and Collaborators
Agenus Inc.

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Responsible Party: Agenus Inc. Identifier: NCT00039000     History of Changes
Obsolete Identifiers: NCT00047359
Other Study ID Numbers: C-100-21
First Posted: June 10, 2002    Key Record Dates
Last Update Posted: September 7, 2012
Last Verified: September 2012
Keywords provided by Agenus Inc.:
Immunotherapy, Cancer, Melanoma, Skin Cancer, tumor
Additional relevant MeSH terms:
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Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas