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Safety and Toxicity Study of Vaccination for Advanced Metastatic Melanoma Patients

NCT01331915 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2012-10-10

No results posted yet for this study

Summary

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.

Conditions

Interventions

BIOLOGICAL

Theravac

Three groups with three doses (50 - 150 - 250 mcg), four times every three weeks. Injection: intradermally and subcutaneously.

Sponsors & Collaborators

  • Institut Pasteur

    collaborator INDUSTRY

  • Cliniques universitaires Saint-Luc- Université Catholique de Louvain

    lead OTHER

Principal Investigators

  • Jean-François Baurain, MD, PhD · Cliniques universitaires Saint-Luc, Centre du Cancer

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2013-10-31

Countries

  • Belgium

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01331915 on ClinicalTrials.gov