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| ID | Type | Description | Link |
|---|---|---|---|
| IND# 13647 |
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| Name | Class |
|---|---|
| NewLink Genetics Corporation | INDUSTRY |
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The purpose of this study is to determine the safety of giving subjects with advanced, recurrent or refractory melanoma the HyperAcute® Melanoma vaccine with a variant of a drug, called Interferon (PEG-Intron®) that is specially formulated to be given on a weekly basis (instead of daily). The study vaccine (HyperAcute®-Melanoma) is made from three types of human melanoma cell lines (grown in the laboratory) in which the genes have been slightly changed. This clinical study will try to discover the safety of the study vaccine combined with PEG-Intron®, its side effects and the potential benefits, if any.
This study will look at the anti-tumor vaccine effect, side effects and toxicity of the HyperAcute® Vaccine with PEG-Intron®. It is hoped that the immune system's response to these genetically engineered melanoma cells and PEG-Intron® will cause a reaction that will make it react to and attack and kill the melanoma cells and keep it from growing, possibly causing the tumors to shrink.
Patients that are eligible are 19 years or older and have been diagnosed with advanced, treatment resistant or recurrent melanoma, an aggressive usually pigmented form of skin cancer.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HyperAcute vaccine | Biological | 1.8 mL weekly | ||
| Pegylated Interferon-Alpha 2b | Drug | 6.0 mcg/kg weekly |
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| Measure | Description | Time Frame |
|---|---|---|
| To conduct scientific studies of patient tumor and peripheral blood samples to determine the mechanism of any observed anti-tumor effect involving the immune responses to the HyperAcute® vaccine alone & combined with PEG-Intron | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the safety and response rate of the administration of the HyperAcute®-Melanoma Vaccine combined with PEG-Intron® into patients with recurrent, refractory, metastatic, or high risk of recurrence melanoma | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Adam I Riker, MD | Ochsner Health System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ochsner Health System | New Orleans | Louisiana | 70121 | United States |
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| Label | URL |
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| Ochsner Health System website | View source |
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| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C417083 | peginterferon alfa-2b |
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