Study of Heat Shock Protein-Peptide Complex (HSPPC-96) Versus IL-2/DTIC for Stage IV Melanoma
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.
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 Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Malignant Melanoma
Intervention
HSPPC-96 or Oncophage
Location
Birmingham
Alabama
United States
Status
Completed
Source
Agenus, Inc.
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00039000
- Information obtained from ClinicalTrials.gov on October 04, 2012
Medical and Biotech [MESH] Definitions
Melanoma, Amelanotic
An unpigmented malignant melanoma. It is an anaplastic melanoma consisting of cells derived from melanoblasts but not forming melanin. (Dorland, 27th ed; Stedman, 25th ed)
Iris Neoplasms
Tumors of the iris characterized by increased pigmentation of melanocytes. Iris nevi are composed of proliferated melanocytes and are associated with neurofibromatosis and malignant melanoma of the choroid and ciliary body. Malignant melanoma of the iris often originates from preexisting nevi.
Hutchinson's Melanotic Freckle
A cellular subtype of malignant melanoma. It is a pigmented lesion composed of melanocytes occurring on sun-exposed skin, usually the face and neck. The melanocytes are commonly multinucleated with a "starburst" appearance. It is considered by many to be the in situ phase of lentigo maligna melanoma.
Cysteinyldopa
Found in large amounts in the plasma and urine of patients with malignant melanoma. It is therefore used in the diagnosis of melanoma and for the detection of postoperative metastases. Cysteinyldopa is believed to be formed by the rapid enzymatic hydrolysis of 5-S-glutathionedopa found in melanin-producing cells.
Dysplastic Nevus Syndrome
Clinically atypical nevi (usually exceeding 5 mm in diameter and having variable pigmentation and ill defined borders) with an increased risk for development of non-familial cutaneous malignant melanoma. Biopsies show melanocytic dysplasia. Nevi are clinically and histologically identical to the precursor lesions for melanoma in the B-K mole syndrome. (Stedman, 25th ed)
Clinical Trials
The goal of this trial is to determine the safety of HSPPC-96 and which route of administration achieves a better response with the vaccine. HSPPC-96 is an immunotherapeutic agent made fro...
Survival Study Of Oncophage® vs. Observation In Patients With Kidney Cancer
Determine whether patients receiving adjuvant HSPPC-96 treatment after surgically resected, locally advanced renal cell carcinoma have improved recurrence-free survival as compared to subj...
The goal of this clinical research study is to learn if patients receiving HSPPC-96 after surgery have an immune response against kidney cancer and how long the immune system response may...
A Study of Recombinant Vaccinia Virus to Treat Malignant Melanoma
The purpose of this research study is to find out whether JX-594 is safe and effective for treating surgically unresectable malignant melanoma.
The Identification of Novel Prognostic Markers in Melanoma
The purpose of this project is to analyze tumour tissue from a group of subjects with malignant melanoma, who have been treated at the Royal Marsden Hospital.
PubMed Articles
Dermoscopic clues in the diagnosis of amelanotic and hypomelanotic malignant melanoma.
The clinical identification of amelanotic malignant melanoma (AMM) and hypomelanotic malignant melanoma (HMM) becomes difficult due to the lack of pigmentation and to the diverse clinical presentation...
Tumor lysis syndrome and malignant melanoma.
Tumor lysis syndrome (TLS) is an oncological emergency that results from massive cytolysis of malignant cells with a sudden release of their contents into the systemic circulation. TLS was rarely desc...
Bladder metastasis of malignant melanoma: a case report and review of literature.
Metastatic malignant melanoma of the bladder is extremely rare in clinical practice with less than 10 cases reported in the last 30 years in the English literature. We report a case of malignant mela...
Ovarian malignant melanoma without evidence of teratoma.
A 46-year-old woman with ovarian malignant melanoma had advanced intraperitoneal metastasis, retroperitoneal and inguinal lymph node metastases. Extensive debulking surgery was performed and chemother...
Comparative Study of Anti-Oncogenic MicroRNA-145 in Canine and Human Malignant Melanoma.
MicroRNA (miRNA; miR)-145 is aberrantly expressed in most of human cancers, and plays a significant role in carcinogenesis and cancer progression. In the current study, we focused on how miR-145 plays...
