Ignite Creation Date:
2024-05-05 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00184067
Status:
TERMINATED
Last Update Posted:
2014-05-21
First Post:
2005-09-12
Brief Title:
Continuation Booster Trial After a Vaccine Combining TyrosinaseGP100MART-1 Peptides Emulsified With Montanide ISA 51 With or Without GM-CSF for Patients With Melanoma
Sponsor:
University of Southern California
Organization:
University of Southern California
Study Overview
Official Title:
A Randomized Phase II Continuation Booster Trial After a Vaccine Combining TyrosinaseGP100MART-1 Peptides Emulsified With Montanide ISA 51 With or Without GM-CSF for Patients With Resected Stages IIBC III and IV Melanoma
Status:
TERMINATED
Status Verified Date:
2014-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Primary PI left institution
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 bodys 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 bodys 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
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 bodys 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 bodys 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None