Ignite Creation Date:
2024-05-05 @ 11:51 PM
Last Modification Date:
2024-10-26 @ 10:41 AM
Study NCT ID:
NCT01435499
Status:
COMPLETED
Last Update Posted:
2016-05-24
First Post:
2011-09-08
Brief Title:
Safety Study of a Melanoma Vaccine GVAX With or Without Cyclophosphamide in Patients With Surgically Resected Melanoma
Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Organization:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study Overview
Official Title:
A Feasibility and Toxicity Study of a Granulocyte-Macrophage Colony-Stimulating Factor GM-CSF Secreting Allogeneic Melanoma Vaccine Administered Alone or in Combination With Cyclophosphamide in Subjects With Surgically Resected At-Risk Melanoma
Status:
COMPLETED
Status Verified Date:
2016-05
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 primary objective of this study is to evaluate the safety and feasibility of administering an allogeneic GM-CSF-secreting lethally irradiated whole melanoma cell vaccine melanoma GVAX alone or in combination with low dose cyclophosphamide CPM for the adjuvant treatment of patients with surgically resected stage IIB-IV melanoma Secondarily the investigators will assess in vitro correlates of anti-melanoma immunization by melanoma GVAX including serological and cellular immune responses in patients treated with either the vaccine alone or the vaccine given with low dose CPM
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