Safety and Toxicity Study of Vaccination for Advanced Metastatic Melanoma Patients (THERAVAC)
In this phase I study, the investigators want to vaccine with THERAVAC® (an inactivated toxin coupled to melanoma antigen) some patients with advanced metastatic melanoma disease.
The primary objective is to analyze the safety of the inreasing doses of vaccine.
The secondary objective is to document whether this vaccine can induce tumor regression in immunized patients.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I/II Study of Therapeutic Vaccination With Escalating Doses of Theravac®, a Proteinic Vector Targeting Dendritic Cells Coupled to a Melanoma Antigen, in Patients With Advanced Metastatic Melanoma.|
- To analyze the safety and toxicity of increasing doses of Theravac® in patients with advanced metastatic melanoma [ Time Frame: the first 3 months of treatment ] [ Designated as safety issue: Yes ]The toxicity will be assess after the treatment (3 months) for the first three patients of each group.
- To determine whether these immunizations result in a detectable immune response [ Time Frame: Up to 24 weeks ] [ Designated as safety issue: No ]PBMC will be obtained from the buffy-coat of 500 ml of venous blood or from 100 ml of venous blood collected before and after immunization.
- To document whether this vaccine can induce tumor regression in immunized patients. [ Time Frame: at week 12 ] [ Designated as safety issue: No ]The NEW RECIST criteria when applicable. For patients with only non-measurable lesion(s) at study entry, tumor response will be assessed descriptively.
|Study Start Date:||September 2010|
|Estimated Primary Completion Date:||October 2013 (Final data collection date for primary outcome measure)|
Theravac® is a recombinant adenylate cyclase toxin from Bordetella pertussis that has been detoxified by mutation of its catalytic domain, and which has been coupled to the Tyrosinase.A2 epitope YMDGTMSQV.
Three groups with three doses (50 - 150 - 250 mcg), four times every three weeks.
Injection: intradermally and subcutaneously.
Other Name: THERAVAC
There are three treatment cohorts and the inclusion of patients in governed by the dose-limiting toxicities in the previous cohort.
- the first three patients will receive a dose of 50 µg of Theravac®
- second cohort of three patients will receive a dose of 150 µg Theravac®
- the third cohort of three patients will receive a dose of 250 µg Theravac® and eventually a total of 14 patients will complete the step with the highest dose.
All the patients will receive four immunizations every three weeks in two intradermal sites and in two subcutaneous sites.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01331915
|Contact: Jean-François Baurain, MD, PhD||0032 2 764 54 email@example.com|
|Contact: Aline Gillain, MSc||0032 2 764 54 firstname.lastname@example.org|
|Cliniques universitaires Saint-Luc, Centre du Cancer||Recruiting|
|Brussels, Belgium, 1200|
|Contact: Jean-François Baurain, MD, PhD 0032 2 764 54 71 email@example.com|
|Contact: Jerome Degueldre, MSc 0032 2 764 75 33 firstname.lastname@example.org|
|Principal Investigator: Jean-François Baurain, MD, PhD|
|Principal Investigator:||Jean-François Baurain, MD, PhD||Cliniques universitaires Saint-Luc, Centre du Cancer|