Ignite Creation Date:
2024-05-06 @ 1:05 AM
Last Modification Date:
2024-10-26 @ 10:59 AM
Study NCT ID:
NCT01729663
Status:
UNKNOWN
Last Update Posted:
2015-09-02
First Post:
2012-11-14
Brief Title:
Phase IIIII Clinical Study CSF470 Plus BCG Plus GM-CSF vs IFN Alpha 2b in Stage IIB IIC and III Melanoma Patients
Sponsor:
Laboratorio Pablo Cassará SRL
Organization:
Laboratorio Pablo Cassará SRL
Study Overview
Official Title:
Randomized Comparative Phase IIIII Study Between Treatment With CSF470 Vaccine Allogeneic Irradiated Plus BCG and MOLGRAMOSTIN rhGM-CSF as Adjuvants and Interferon-alfa 2b IFN-ALPHA in Stages IIB IIC and III Post Surgery Cutaneous Melanoma Patients
Status:
UNKNOWN
Status Verified Date:
2015-08
Last Known Status:
RECRUITING
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:
Randomized open Phase II-III study comparative between treatment with CSF-470 vaccine allogeneic irradiated with BCG and molgramostin rHuGM-CSF as adjuvants and interferon alfa 2b IFN-alpha2b treatment in stages IIB IIC o III AJCC post-surgery cutaneous melanoma patients This study has been approved by ANMAT Administración Nacional de Medicamentos Alimentos y Tecnología Médica ANMAT number 15562011 wwwanmatgovar
The study Institution is Instituto Médico Especializado Alexander Fleming Ciudad Autónoma de Buenos Aires Argentina The Sponsor is Laboratory Pablo Cassará LPC SRL
Study population include a total of 108 patients 72 patients will receive CSF470 vaccine and 36 patients will receive alpha IFN-alpha 2b for a total of 24 months
CSF-470 treatment will consist of four vaccine doses id injection three weeks apart then one dose every two months for the first year and them every three months for the second year
Each vaccine consist of a mixture of 176106 melanoma cells from four melanoma cell lines not genetically modified and lethally irradiated As adjuvant BCG 120 µg prot the first day and rHuGM-CSF Molgramostim 400 µg fractionated in four days doses will be used
IFN-alpha 2b treatment will consist of sc injection of 10 million units MU 5 tw for four weeks and then 5 MU 3tw for 23 months
Both treatments will also compare quality of life QOL and study a possible correlation in the CSF470 vaccine arm between the induced immune response and clinical outcome
The study Institution is Instituto Médico Especializado Alexander Fleming Ciudad Autónoma de Buenos Aires Argentina The Sponsor is Laboratory Pablo Cassará LPC SRL
Study population include a total of 108 patients 72 patients will receive CSF470 vaccine and 36 patients will receive alpha IFN-alpha 2b for a total of 24 months
CSF-470 treatment will consist of four vaccine doses id injection three weeks apart then one dose every two months for the first year and them every three months for the second year
Each vaccine consist of a mixture of 176106 melanoma cells from four melanoma cell lines not genetically modified and lethally irradiated As adjuvant BCG 120 µg prot the first day and rHuGM-CSF Molgramostim 400 µg fractionated in four days doses will be used
IFN-alpha 2b treatment will consist of sc injection of 10 million units MU 5 tw for four weeks and then 5 MU 3tw for 23 months
Both treatments will also compare quality of life QOL and study a possible correlation in the CSF470 vaccine arm between the induced immune response and clinical outcome
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