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Melanoma (Skin)Phase 2NCT00086866

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

A Phase 2 study testing D1/3-MAGE-3-His fusion protein, SB-AS02B adjuvant and SB-AS15 adjuvant in people with Melanoma (Skin), run by European Organisation for Research and Treatment of Cancer - EORTC at 21 sites in 7 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Melanoma (Skin)
What is being tested?
D1/3-MAGE-3-His fusion protein, SB-AS02B adjuvant and SB-AS15 adjuvant
How many people
165 participants
Where
21 sitesin 7 countries
Study dates
May 2004to Jan 2007
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

21 sites in 7 countries.

21 sites in 7 countries

France6 sites

  • Clinique Sainte-Marguerite

    Hyères, 83400

  • Centre Hospitalier Regional et Universitaire de Lille

    Lille, 59037

  • Hopital St. Eloi

    Montpellier, 34295

  • CHR Hotel Dieu

    Nantes, 44093

  • Institut Curie Hopital

    Paris, 75248

  • Institut Gustave Roussy

    Villejuif, F-94805

Other trials in France

Italy4 sites

  • Centro di Riferimento Oncologico - Aviano

    Aviano, 33081

  • Istituto Nazionale per lo Studio e la Cura dei Tumori

    Naples, 80131

  • Azienda Ospedaliera di Padova

    Padova, 35128

  • Universita di Siena

    Siena, 53100

Other trials in Italy

Germany3 sites

  • Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin

    Berlin, D-12200

  • Klinikum der Stadt Mannheim

    Mannheim, D-68135

  • Universitaets - Kinderklinik Wuerzburg

    Würzburg, D-97080

Other trials in Germany

Belgium2 sites

  • Institut Jules Bordet

    Brussels, 1000

  • Hopital Universitaire Erasme

    Brussels, 1070

Other trials in Belgium

Netherlands2 sites

  • Leiden University Medical Center

    Leiden, 2300 RC

  • Daniel Den Hoed Cancer Center at Erasmus Medical Center

    Rotterdam, 3008 AE

Other trials in Netherlands

Spain2 sites

  • Hospital Clinic de Barcelona

    Barcelona, 08036

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

Other trials in Spain

United Kingdom2 sites

  • Saint Bartholomew's Hospital

    London, England, EC1A 7BE

  • Christie Hospital NHS Trust

    Manchester, England, M20 4BX

Other trials in United Kingdom

About this study

Official title: Randomized, 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

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.

Read the 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.

Conditions
Melanoma (Skin)
Being tested
D1/3-MAGE-3-His fusion protein, SB-AS02B adjuvant, SB-AS15 adjuvant
Keywords
stage III melanoma, stage IV melanoma, recurrent melanoma
Medical subject headings
Melanoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • D1/3-MAGE-3-His fusion proteinBiological

  • SB-AS02B adjuvantBiological

  • SB-AS15 adjuvantBiological

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Response rate (complete response and partial response) as assessed by RECIST criteria

  2. Vaccine-related toxicity as assessed by CTCAE v3

Secondary outcomes (4)

  1. Rate of stabilization as assessed by RECIST criteria

  2. Rate of mixed response as assessed by RECIST criteria

  3. Rate of immune response

  4. Progression-free survival

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jul 2004 (estimated)
  2. Study startMay 2004
  3. Primary completionJan 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Masking
None (open label)
Enrolment
165 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00086866
Sponsor's protocol ID
EORTC-16032-18031
Other IDs
EORTC-18031, EORTC-16032, GSK-249553/008, 2004-001937-40, 2004
Status last verified
Feb 2015
First submitted
8 Jul 2004
Last updated
10 Feb 2015
Results posted
No

Publications

  • Kruit WH, Suciu S, Dreno B, et al.: Immunization with recombinant MAGE-A3 protein combined with adjuvant systems AS15 or AS02B in patients with unresectable and progressive metastatic cutaneous melanoma: A randomized open-label phase II study of the EORTC Melanoma Group (16032- 18031). [Abstract] J Clin Oncol 26 (Suppl 15): A-9065, 2008.

  • Louahed J, Gruselle O, Gaulis S, et al.: Expression of defined genes identified by pretreatment tumor profiling: association with clinical responses to the GSK MAGE- A3 immunotherapeutic in metastatic melanoma patients (EORTC 16032-18031). [Abstract] J Clin Oncol 26 (Suppl 15): A-9045, 2008.

  • Kruit WH, Suciu S, Dreno B, Mortier L, Robert C, Chiarion-Sileni V, Maio M, Testori A, Dorval T, Grob JJ, Becker JC, Spatz A, Eggermont AM, Louahed J, Lehmann FF, Brichard VG, Keilholz U. Selection of immunostimulant AS15 for active immunization with MAGE-A3 protein: results of a randomized phase II study of the European Organisation for Research and Treatment of Cancer Melanoma Group in Metastatic Melanoma. J Clin Oncol. 2013 Jul 1;31(19):2413-20. doi: 10.1200/JCO.2012.43.7111. Epub 2013 May 28.

    PubMed 23715572

  • Ulloa-Montoya F, Louahed J, Dizier B, Gruselle O, Spiessens B, Lehmann FF, Suciu S, Kruit WH, Eggermont AM, Vansteenkiste J, Brichard VG. Predictive gene signature in MAGE-A3 antigen-specific cancer immunotherapy. J Clin Oncol. 2013 Jul 1;31(19):2388-95. doi: 10.1200/JCO.2012.44.3762. Epub 2013 May 28.

    PubMed 23715562

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing D1/3-MAGE-3-His fusion protein, SB-AS02B adjuvant and SB-AS15 adjuvant in people with Melanoma (Skin), run by European Organisation for Research and Treatment of Cancer - EORTC at 21 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 10 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in France, Italy, Germany, Belgium, Netherlands and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Response rate (complete response and partial response) as assessed by RECIST criteria. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00086866, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2015.

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