Study of Heat Shock Protein-Peptide Complex (HSPPC-96) Versus IL-2/DTIC for Stage IV Melanoma
This study has been completed.
Information provided by (Responsible Party):
First received: June 6, 2002
Last updated: September 6, 2012
Last verified: September 2012
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.
Drug: HSPPC-96 or Oncophage
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
||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
| Estimated Enrollment:
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||December 2005 (Final data collection date for primary outcome measure)
- 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.
- To determine frequency of adverse events in subjects randomized to HSPPC-96.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
(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.
- 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.
- 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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00039000
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||June 6, 2002
||September 6, 2012
||United States: Food and Drug Administration
Keywords provided by Agenus, Inc.:
Immunotherapy, Cancer, Melanoma, Skin Cancer, tumor
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on July 29, 2014
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas