Ignite Creation Date:
2024-05-05 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00197912
Status:
COMPLETED
Last Update Posted:
2010-04-26
First Post:
2005-09-12
Brief Title:
Dendritic Cell Based Therapy of Malignant Melanoma
Sponsor:
Herlev Hospital
Organization:
Herlev Hospital
Study Overview
Official Title:
Vaccination With Autologous Dendritic Cells Pulsed With Tumor Antigens for Treatment of Patients With Malignant Melanoma Phase III Study
Status:
COMPLETED
Status Verified Date:
2009-07
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 aim of the study is to show if vaccination with autologous dendritic cells pulsed with peptides or tumor lysate in combination with adjuvant cytokines and Cyclophosphamide can induce a measurable immune response in patients with metastatic malignant melanoma and to evaluate the clinical effect objective response rate of the vaccination regime
Detailed Description:
Eligible patients receive vaccination with tumor antigen pulsed autologous monocyte-derived mature dendritic cells with a fixed interval The dendritic cells are generated from leukapheresis products and frozen after antigen loading
HLA A2 positive patients are treated with PADRE and oncopeptide pulsed DC p53 survivin and telomerase peptides HLA A2 negative patients are treated with KLH and tumorlysate pulsed DC autologous or allogeneic Each patient is given 6 immunizations with at least 5x106 peptidelysate pulsed autologous DC Vaccination 1-4 is given weekly and 4-6 at 2-week intervals Those patients who exhibit stable disease partial response or complete response after 6 injections will be given 4 more vaccinations at 2-week interval The vaccine is applied by intradermal injection near the inguinal region
IL-2 2 MIU sc day 2-6 Cyclophosphamide Sendoxan Baxter AS 50 mg twice a day bi-weekly and 200 mg Celecoxib Celebra Pfizer daily are used Scans and re-staging tests are performed at scheduled intervals throughout the study
HLA A2 positive patients are treated with PADRE and oncopeptide pulsed DC p53 survivin and telomerase peptides HLA A2 negative patients are treated with KLH and tumorlysate pulsed DC autologous or allogeneic Each patient is given 6 immunizations with at least 5x106 peptidelysate pulsed autologous DC Vaccination 1-4 is given weekly and 4-6 at 2-week intervals Those patients who exhibit stable disease partial response or complete response after 6 injections will be given 4 more vaccinations at 2-week interval The vaccine is applied by intradermal injection near the inguinal region
IL-2 2 MIU sc day 2-6 Cyclophosphamide Sendoxan Baxter AS 50 mg twice a day bi-weekly and 200 mg Celecoxib Celebra Pfizer daily are used Scans and re-staging tests are performed at scheduled intervals throughout the study
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