Suspended

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

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

D1/3-MAGE-3-His fusion protein

+ SB-AS02B adjuvant
+ SB-AS15 adjuvant
Biological
Who is being recruted

Melanoma (Skin)

Over 18 Years
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: May 2004

Summary

Principal SponsorEuropean Organisation for Research and Treatment of Cancer - EORTC
Last updated: February 10, 2015
Sourced from a government-validated database.Claim as a partner
Study start date: May 1, 2004Actual date on which the first participant was enrolled.

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. 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.

Official TitleRandomized, Open Phase II Study of Immunization With the Recombinant MAGE-3 Protein Combined With Adjuvant AS02B or AS15 in Patients With Unresectable and Progressive Metastatic Cutaneous Melanoma 
Principal SponsorEuropean Organisation for Research and Treatment of Cancer - EORTC
Last updated: February 10, 2015
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
165 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation
: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.

None (Single-arm trial)
: If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind
: Participants do not know which treatment they are receiving, but researchers do.

Double-blind
: Neither participants nor researchers know which treatment is given.

Triple-blind
: Participants, researchers, and outcome assessors do not know which treatment is given.

Quadruple-blind
: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Melanoma (Skin)
Criteria

DISEASE CHARACTERISTICS: * Histologically confirmed cutaneous melanoma * Unresectable stage III OR stage IV M1a disease * Documented progressive disease within the past 12 weeks * Measurable disease * Skin, soft tissue, or lymph node metastasis allowed provided the disease is not amenable to curative treatment with surgery * Tumor must express the MAGE-3 gene by reverse transcription polymerase chain reaction analysis (more than 1% of the positive MAGE-3 control included in the assay) * No visceral metastases within the past 56 days by imaging PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-1 Life expectancy * Not specified Hematopoietic * Hemoglobin ≥ lower limit of normal (LLN) * WBC ≥ LLN * Lymphocyte count ≥ LLN * Platelet count ≥ LLN * No bleeding disorders Hepatic * Bilirubin ≤ upper limit of normal (ULN) * Lactic dehydrogenase ≤ ULN * AST and ALT ≤ 2 times ULN * PT and aPTT normal * Hepatitis B surface antigen negative (antibody test may be positive) * Hepatitis C antibody negative Renal * Creatinine ≤ ULN Cardiovascular * No clinically significant heart disease (CTC grade III or IV) Immunologic * No autoimmune disease (vitiligo allowed) * No anti-nuclear antibody titer ≥ 1/320 OR equal to 1/160 AND auto-antibodies directed against specific auto-antigens * No immunodeficiency * No active infection requiring antibiotic therapy * HIV negative Other * Not pregnant * Negative pregnancy test * Fertile patients must use effective contraception during and for 3 months after study participation * No other malignancy within the past 5 years except surgically cured basal cell or squamous cell skin cancer or carcinoma in situ of the cervix * No other serious acute or chronic illness requiring concurrent medications * No psychological, familial, sociological, or geographical condition that would preclude study compliance PRIOR CONCURRENT THERAPY: Biologic therapy * More than 8 weeks since prior adjuvant vaccine therapy * No prior vaccine therapy containing a MAGE-3 antigen * No prior vaccine therapy for metastatic melanoma * No concurrent immunomodulating agents (e.g., BCG) Chemotherapy * No prior systemic chemotherapy * No concurrent chemotherapy Endocrine therapy * No concurrent corticosteroids * Concurrent prednisone or equivalent allowed provided the dose is ≤ 40 mg/day and treatment duration is for no more than 3 weeks * Concurrent inhaled and topical steroids are allowed Radiotherapy * No prior radiotherapy to the spleen * No concurrent radiotherapy to \> 20% of all existing lesions (i.e., target lesions, non-target lesions, and nonmeasurable lesions) * Concurrent local low-dose (≤ 20 Grays) radiotherapy allowed Surgery * Recovered from prior surgery or biopsy * No prior organ allograft * No prior splenectomy * Concurrent surgery to a limited number of lesions allowed for patients with a complete response, partial response, or stable disease after at least 3 courses of study therapy Other * No prior systemic anticancer therapy * More than 4 weeks since prior isolated limb perfusion therapy * No other concurrent anticancer therapy * No other concurrent immunosuppressive agents


Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives
Study Objectives
Primary Objectives

Secondary Objectives


Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 21 locations
Suspended
Institut Jules BordetBrussels, BelgiumSee the location
Suspended
Hopital Universitaire ErasmeBrussels, Belgium
Suspended
Clinique Sainte-MargueriteHyeres, France
Suspended
Centre Hospitalier Regional et Universitaire de LilleLille, France

Suspended21 Study Centers