Continuation Booster Trial After a Vaccine Combining Tyrosinase/GP100/MART-1 Peptides Emulsified With Montanide ISA 51 With or Without GM-CSF for Patients With Melanoma
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|ClinicalTrials.gov Identifier: NCT00184067|
Recruitment Status : Terminated (Primary PI left institution)
First Posted : September 16, 2005
Last Update Posted : May 21, 2014
This is a study of a melanoma vaccine. Study participants will have melanoma that invaded deeply and spread to lymph nodes or another location. Although the participants' melanoma has been removed, there is a greater than 1 out of 2 chance it will return. There will be approximately 40 subjects in this study. The patients will have already taken part in a melanoma vaccine study, and in this current study, they will continue to receive booster injections of a similar vaccine given for two additional years.
This study will test an experimental vaccine. The vaccine contains peptides which are fragments of substances made by most melanomas. The substances are tyrosinase, gpl00 and melanoma antigen recognized by T cells (MART-1). The vaccine also includes an assistant called Montanide ISA 51. The assistant stimulates the immune system. This study will also test the effects of a second assistant granulocyte-macrophage colony-stimulating factor (GM-CSF). All participants will receive the vaccine and assistant Montanide ISA 51, but only half will receive the assistant GM-CSF. The patients have a one in two chance of receiving the assistant called GM-CSF. The main purpose of this study is to find out if the booster injections increase the body's immunity to melanoma and prevent its level of immunity from getting lower over time. The investigators also wish to know if the GM-CSF increases the body's immunity to melanoma when given with the melanoma vaccine.
The vaccine and assistant Montanide ISA 51 are not approved by the Food and Drug Administration (FDA). The assistant GM-CSF is approved by the FDA to increase infection-fighting white blood cells after chemotherapy. It is not approved by the FDA for treatment of melanoma. However, the FDA is permitting the vaccine and the assistants to be tested in this study.
|Condition or disease||Intervention/treatment||Phase|
|Melanoma||Biological: Montanide ISA 51||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||23 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Phase II Continuation Booster Trial After a Vaccine Combining Tyrosinase/GP100/MART-1 Peptides Emulsified With Montanide ISA 51 With or Without GM-CSF for Patients With Resected Stages IIB/C, III, and IV Melanoma|
|Study Start Date :||May 2004|
|Actual Primary Completion Date :||April 2007|
|Actual Study Completion Date :||September 2009|
Experimental: Peptide vaccine with Montanide ISA 51 + GM-CSF
Peptide vaccine with Montanide ISA 51 GM-CSF
Biological: Montanide ISA 51
Active Comparator: Peptide vaccine with Montanide ISA 51
Peptide vaccine with Montanide ISA 51
Biological: Montanide ISA 51
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): NCT00184067
|United States, California|
|USC/Norris Comprehensive Cancer Center|
|Los Angeles, California, United States, 90033|
|Principal Investigator:||Jeffrey Weber||University of Southern California|