Active Specific Intranodal Immunotherapy of Recombinant Vaccinia Virus in Locally Advanced to Metastatic Melanoma
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|ClinicalTrials.gov Identifier: NCT00116597|
Recruitment Status : Completed
First Posted : June 30, 2005
Last Update Posted : December 2, 2009
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.
|Condition or disease||Intervention/treatment||Phase|
|Melanoma||Genetic: Intranodal immunization with a recombinant vaccinia virus expressing 5 transgenes Biological: Intranodal booster immunizations with synthetic melanoma associated epitopes||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 I/II Trial in Patients With Stages IIb to IV Melanoma|
|Study Start Date :||November 2002|
|Actual Primary Completion Date :||July 2007|
|Actual Study Completion Date :||December 2008|
- Safety evaluation
- Clinical response
- Immune response assessment
- Survival (disease-free survival [DFS], overall survival [OS])
- Dose adaptation
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00116597
|University Hospital Basel|
|Basel, Switzerland, 4031|
|Principal Investigator:||Michel Adamina, M.D.||University Hospital, Basel, Switzerland|
|Study Chair:||Daniel Oertli, M.D.||University Hospital, Basel, Switzerland|
|Study Director:||Michael Heberer, M.D.||University Hospital, Basel, Switzerland|
|Principal Investigator:||Giulio C Spagnoli, M.D.||University Hospital, Basel, Switzerland|
|Principal Investigator:||Walter R Marti, M.D.||University Hospital, Basel, Switzerland|