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Sponsored by: |
Norris Comprehensive Cancer Center |
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Information provided by: | Norris Comprehensive Cancer Center |
ClinicalTrials.gov Identifier: | NCT00184067 |
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 | Intervention | Phase |
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Melanoma |
Biological: Montanide ISA 51 |
Phase II |
Study Type: | Interventional |
Study Design: | Randomized, Single Blind, Uncontrolled, Parallel Assignment |
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 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Inclusion Criteria:
Patients who have completed protocol 10M-01-1 or 10M-00-4 are eligible for this study provided that:
Exclusion Criteria:
United States, California | |
USC/Norris Comprehensive Cancer Center | |
Los Angeles, California, United States, 90033 |
Principal Investigator: | Jeffrey Weber | Norris Comprehensive Cancer Center |
Study ID Numbers: | 10M-03-8 |
Study First Received: | September 12, 2005 |
Last Updated: | January 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00184067 |
Health Authority: | United States: Institutional Review Board |
Neuroectodermal Tumors Nevus, Pigmented Neoplasms, Germ Cell and Embryonal Neuroepithelioma |
Nevus Neuroendocrine Tumors Melanoma |
Neoplasms Neoplasms by Histologic Type Neoplasms, Nerve Tissue Nevi and Melanomas |