A Phase II Study of an Anti-Tumor Immunotherapy Regimen Comprised of Pegylated Interferon-Alpha 2b and HyperAcute Melanoma Vaccine for Subjects With Advanced 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.|
|ClinicalTrials.gov Identifier: NCT00746746|
Recruitment Status : Unknown
Verified September 2008 by Ochsner Health System.
Recruitment status was: Active, not recruiting
First Posted : September 4, 2008
Last Update Posted : January 13, 2011
|Condition or disease||Intervention/treatment||Phase|
|Melanoma||Biological: HyperAcute vaccine Drug: Pegylated Interferon-Alpha 2b||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of an Anti-Tumor Immunotherapy Regimen Comprised of Pegylated Interferon-Alpha 2b (PEG-Intron)and HyperAcute Melanoma Vaccine for Subjects With Advanced Melanoma|
|Study Start Date :||June 2008|
|Estimated Primary Completion Date :||June 2010|
|Estimated Study Completion Date :||June 2011|
- Biological: HyperAcute vaccine
1.8 mL weekly
- Drug: Pegylated Interferon-Alpha 2b
6.0 mcg/kg weeklyOther Name: PEG-Intron
- 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 [ Time Frame: 2 years ]
- 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 [ Time Frame: 2 years ]
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 ClinicalTrials.gov identifier (NCT number): NCT00746746
|United States, Louisiana|
|Ochsner Health System|
|New Orleans, Louisiana, United States, 70121|
|Principal Investigator:||Adam I Riker, MD||Ochsner Health System|