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Active Specific Intranodal Immunotherapy of Recombinant Vaccinia Virus in Locally Advanced to Metastatic Melanoma

NCT00116597 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2009-12-02

No results posted yet for this study

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.

Conditions

Interventions

GENETIC

Intranodal immunization with a recombinant vaccinia virus expressing 5 transgenes

BIOLOGICAL

Intranodal booster immunizations with synthetic melanoma associated epitopes

Sponsors & Collaborators

  • University Hospital, Basel, Switzerland

    lead OTHER

Principal Investigators

  • Michel Adamina, M.D. · University Hospital, Basel, Switzerland

  • Daniel Oertli, M.D. · University Hospital, Basel, Switzerland

  • Michael Heberer, M.D. · University Hospital, Basel, Switzerland

  • Giulio C Spagnoli, M.D. · University Hospital, Basel, Switzerland

  • Walter R Marti, M.D. · University Hospital, Basel, Switzerland

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
2002-11-30
Primary Completion
2007-07-31
Completion
2008-12-31

Countries

  • Switzerland

Study Locations

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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 NCT00116597 on ClinicalTrials.gov