Vaccine Therapy in Treating Patients With Stage III or Stage IV Melanoma That Cannot Be Removed With Surgery

Phase 2

• Conditions: Melanoma (Skin)

• Registration Number: NCT00086866
• Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC

Brief Summary

RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.

PURPOSE: This randomized phase II trial is studying two different regimens of vaccine therapy and comparing them to see how well they work in treating patients with stage III or stage IV melanoma that cannot be removed with surgery.

Detailed Description

OBJECTIVES:

Primary

* Compare the objective response rate (complete and partial response) in patients with unresectable stage III or stage IV M1a cutaneous melanoma immunized with vaccine comprising D1/3-MAGE-3-His fusion protein and SB-AS02B adjuvant vs SB-AS15 adjuvant.

* Compare the activity of SB-AS02B adjuvant vs SB-AS15 adjuvant, in terms of maximizing the antigenicity of MAGE-3, in patients treated with these regimens.

* Compare the rate of grade 3/4 vaccine-related toxicity in patients treated with these regimens.

Secondary

* Compare progression-free survival in patients treated with these regimens.

OUTLINE: This is a randomized, open label, parallell-group, multicenter study. Patients are stratified according to disease stage (III in transit vs other stage III vs IV), presence of lesion ≥ 20 mm (yes vs no), and participating center. Patients are randomized to 1 of 2 treatment arms.

* Induction therapy

* Arm I: Patients receive immunization comprising D1/3-MAGE-3-His fusion protein and SB-AS02B adjuvant intramuscularly (IM) once weekly on weeks 1, 3, 5, 7, 9, and 11.

* Arm II: Patients receive immunization comprising D1/3-MAGE-3-His fusion protein SB-AS15 adjuvant IM once weekly on weeks 1, 3, 5, 7, 9, and 11.

Patients achieving a clinical complete response (CR), partial response (PR), stable disease (SD), or slow progressive disease (SPD) proceed to maintenance therapy.

* Maintenance therapy: Patients in both arms receive immunization (according to their randomized arm) once weekly on weeks 15, 18, 21, 24, 27, 30, 34, 40, 46, and 52.

Patients maintaining a CR, PR, or SD proceed to long-term treatment.

* Long-term treatment: Beginning 3 months after completion of maintenance therapy, patients in both arms receive immunization (according to their randomized arm) once every 3 months for 4 courses and then once every 6 months for 4 courses.

Treatment continues in both arms in the absence of disease progression that does not correspond to SPD status, unacceptable toxicity, or the diagnosis of an autoimmune disease.

Patients are followed every 12 weeks.

PROJECTED ACCRUAL: A total of 68 patients (34 patients per treatment arm) will be accrued for this study.

Study Timeline

• Study Start: 2004-05
• Study First Submitted: 2004-07-08
• Study First Submitted QC: 2004-07-09
• Study First Posted: 2004-07-12
• Primary Completion: 2007-01
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-09
• Last Update Posted: 2015-02-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 165

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Vaccine-related toxicity as assessed by CTCAE v3
Response rate (complete response and partial response) as assessed by RECIST criteria

Secondary Outcome Measures

Name	Time	Method
Rate of mixed response as assessed by RECIST criteria
Progression-free survival
Rate of stabilization as assessed by RECIST criteria
Rate of immune response

Trial Locations

Locations (21)

Institut Jules Bordet; 🇧🇪 Brussels, Belgium

Hopital Universitaire Erasme; 🇧🇪 Brussels, Belgium

Christie Hospital NHS Trust; 🇬🇧 Manchester, England, United Kingdom

Daniel Den Hoed Cancer Center at Erasmus Medical Center; 🇳🇱 Rotterdam, Netherlands

Leiden University Medical Center; 🇳🇱 Leiden, Netherlands

Centre Hospitalier Regional et Universitaire de Lille; 🇫🇷 Lille, France

Universitaets - Kinderklinik Wuerzburg; 🇩🇪 Wuerzburg, Germany

Hospital Clinic de Barcelona; 🇪🇸 Barcelona, Spain

Institut Curie Hopital; 🇫🇷 Paris, France

CHR Hotel Dieu; 🇫🇷 Nantes, France

Clinique Sainte-Marguerite; 🇫🇷 Hyeres, France

Hopital St. Eloi; 🇫🇷 Montpellier, France

Hospital Universitario 12 de Octubre; 🇪🇸 Madrid, Spain

Saint Bartholomew's Hospital; 🇬🇧 London, England, United Kingdom

Institut Gustave Roussy; 🇫🇷 Villejuif, France

Centro di Riferimento Oncologico - Aviano; 🇮🇹 Aviano, Italy

Istituto Nazionale per lo Studio e la Cura dei Tumori; 🇮🇹 Naples, Italy

Azienda Ospedaliera di Padova; 🇮🇹 Padova, Italy

Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin; 🇩🇪 Berlin, Germany

Klinikum der Stadt Mannheim; 🇩🇪 Mannheim, Germany

Universita di Siena; 🇮🇹 Siena, Italy