Ignite Creation Date:
2024-05-05 @ 12:07 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00257465
Status:
COMPLETED
Last Update Posted:
2015-12-03
First Post:
2005-11-22
Brief Title:
Trial of Autologous Hapten-Modified Vaccine in Patients With Stage III or IV Melanoma
Sponsor:
AVAX Technologies
Organization:
AVAX Technologies
Study Overview
Official Title:
M-Vax A Feasibility and Bio-Equivalence Study Using a DNP-Modified Autologous Melanoma Tumor Cell Vaccine as Therapy in Patients With Stage III or IV Melanoma
Status:
COMPLETED
Status Verified Date:
2015-12
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 whether a vaccine composed of patients own melanoma cells treated with the chemical dinitrophenyl DNPcalled a hapten is safe and stimulates an immune response to patients own cancer cells
Detailed Description:
Patients with stage III or IV melanoma need to have at least one tumor mass of at least 25 cm about 1 inch diameter than can be removed for vaccine production If the vaccine is successfully made and if the patient is eligible the patient will be assigned to receive one of 4 doses of the vaccine include one group that will receive a zero dose All patients will receive injections of their vaccine as part of immune system testing and will receive low dose cyclophosphamide and BCG Eight injections of the vaccine will be administered as an injection into the skin of the arm over a 6 month period Before and after vaccine administration patients will be tested for immunity to their own melanoma cells by DTH testing which is similar to a tuberculosis test All side effects caused by the vaccine will be recorded
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