Ignite Creation Date:
2025-12-25 @ 5:18 AM
Ignite Modification Date:
2025-12-26 @ 4:26 AM
Study NCT ID:
NCT01008527
Status:
COMPLETED
Last Update Posted:
2015-09-24
First Post:
2009-11-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Phase I Oncovir Poly IC:LC and NY-ESO-1/gp100
Sponsor:
H. Lee Moffitt Cancer Center and Research Institute
Organization:
Study Overview
Official Title:
A Phase I Study of Poly IC:LC and NY-ESO-1/gp100 Peptides Either Emulsified With Montanide ISA 51 or in Aqueous Solution With Escalating Doses of CP 870,893 in the Treatment of Subjects With Resected Stage III or Stage IV Melanoma
Status:
COMPLETED
Status Verified Date:
2015-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine what side effects CP 870,893 may cause when given with an immune stimulant called Oncovir poly IC:LC along with a melanoma vaccine. The CP 870,893, the Oncovir poly IC:LC and the melanoma vaccine are investigational drugs that have not been combined in patients before, and that have not been approved for sale by the Food and Drug Administration. The Oncovir poly IC:LC is intended to stimulate the body's immune system.
Detailed Description:
Antibodies such as CP 870,893 are chemicals made by immune cells naturally found in the human body. CP 870,893 was produced in cells grown from a hamster but is fully human in composition. The vaccine contains peptides (pieces) from two different proteins called NY-ESO-1 and gp100. Each one is made by 50-100% of melanomas. These proteins can be recognized by the immune system. They will be injected under the skin of the participant's thigh in combination with, or without an oil-based substance, called "Montanide ISA 51 VG". The Montanide ISA 51 VG is an adjuvant or "assistant" which stimulates the body's immune system. The peptides in the vaccine, the Montanide ISA 51 VG, the Oncovir poly IC:LC and the CP 870,893 antibody are not approved by the Food and Drug Administration (FDA) but the FDA is permitting their use in this study. It is believed that the CP 870,893 and the Oncovir poly IC:LC will boost the body's immune response against the melanoma vaccine, although this vaccine has not been proven to help the patient's melanoma.
Study Oversight
Has Oversight DMC:
True
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?: