Ignite Creation Date:
2024-05-05 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00116597
Status:
COMPLETED
Last Update Posted:
2009-12-02
First Post:
2005-06-29
Brief Title:
Active Specific Intranodal Immunotherapy of Recombinant Vaccinia Virus in Locally Advanced to Metastatic Melanoma
Sponsor:
University Hospital Basel Switzerland
Organization:
University Hospital Basel Switzerland
Study Overview
Official Title:
Active Specific Intranodal Immunotherapy With a Recombinant Vaccinia Virus Expressing Three Melanoma Associated Epitopes and Two Costimulatory Molecules Followed by Immunization With Synthetic Melanoma Associated Epitopes A Phase III Trial in Patients With Stages IIb to IV Melanoma
Status:
COMPLETED
Status Verified Date:
2009-12
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 assess intranodal immunotherapy in locally advanced to metastatic melanoma patients American Joint Committee on Cancer AJCC stages IIb to IV
For this the investigators capitalize on their previous melanoma clinical trial published by Zajac P et al in Human Gene Ther 2003 and take advantage of a proprietary recombinant vaccinia virus replication inactivated expressing 5 minigenes 3 melanoma associated antigens and 2 costimulatory molecules Immunization with the recombinant vaccinia virus is followed by 3 boosts with soluble synthetic melanoma associated antigens
The patients are immunized intranodally groin lymph node under ultrasonographic guidance in an outpatient clinic The protocol foresees 2 cycles of immunotherapy for alternate weeks and lasts 15 weeks
For this the investigators capitalize on their previous melanoma clinical trial published by Zajac P et al in Human Gene Ther 2003 and take advantage of a proprietary recombinant vaccinia virus replication inactivated expressing 5 minigenes 3 melanoma associated antigens and 2 costimulatory molecules Immunization with the recombinant vaccinia virus is followed by 3 boosts with soluble synthetic melanoma associated antigens
The patients are immunized intranodally groin lymph node under ultrasonographic guidance in an outpatient clinic The protocol foresees 2 cycles of immunotherapy for alternate weeks and lasts 15 weeks
Detailed Description:
The investigators have conducted a phase III clinical trial based on the intradermal administration to stage IIIIV melanoma patients of a recombinant vaccinia virus encoding tumor associated antigens and costimulatory epitopes for the priming of immune responses followed by boosts with corresponding synthetic peptides Zajac P et al in Human Gene Ther 2003 Specific cytotoxic T cells could be induced in a majority of patients following priming but sustained responsiveness could not be maintained by peptide boosting on a long term basis Emerging evidence supports the notion that expansion of specific T cells requires trafficking of antigen presenting cells loaded with specific determinants to lymphatic nodes as induced among others by pro-inflammatory stimuli Therefore we now adopt the intranodal injection of the immunogenic formulations As for the former melanoma active specific immunotherapy trial GM-CSF is used as a supporting cytokine The epitopes considered are expressed either all or some of them in over 90 of the melanomas in Western countries namely we immunize with Mart-1Melan-A epitope 27-35 Gp-100 epitope 280-288 and tyrosinase epitope 1-9 As a consequence HLA-A2 positivity is mandatory for inclusion in the trial The 2 costimulatory molecules expressed by cells infected with our replication-incompetent recombinant vaccinia virus are B71 CD80 and B72 CD86
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| SNF grant NPF 37 4037-55151 | None | None | None |