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

NCT00086866 | Unknown Phase 2

• 5 other identifiers: EORTC-16032-18031EORTC-18031EORTC-16032GSK-249553/0082004-001937-40
• Study Type: interventional
• Target: 165
• Locations: 7 countries
• Sites: 21

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.

Conditions

Melanoma (Skin)

Keywords

stage III melanoma; stage IV melanoma; recurrent melanoma

Outcome Measures

Primary Outcomes (2)

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

• Vaccine-related toxicity as assessed by CTCAE v3

Secondary Outcomes (4)

• Rate of stabilization as assessed by RECIST criteria

• Rate of mixed response as assessed by RECIST criteria

• Rate of immune response

• Progression-free survival

Interventions

D1/3-MAGE-3-His fusion protein BIOLOGICAL

SB-AS02B adjuvant BIOLOGICAL

SB-AS15 adjuvant BIOLOGICAL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• European Organisation for Research and Treatment of Cancer - EORTC: lead

Study Sites (21)

Institut Jules Bordet

Brussels, 1000, Belgium

Location

Hopital Universitaire Erasme

Brussels, 1070, Belgium

Location

Clinique Sainte-Marguerite

Hyères, 83400, France

Location

Centre Hospitalier Regional et Universitaire de Lille

Lille, 59037, France

Location

Hopital St. Eloi

Montpellier, 34295, France

Location

CHR Hotel Dieu

Nantes, 44093, France

Location

Institut Curie Hopital

Paris, 75248, France

Location

Institut Gustave Roussy

Villejuif, F-94805, France

Location

Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin

Berlin, D-12200, Germany

Location

Klinikum der Stadt Mannheim

Mannheim, D-68135, Germany

Location

Universitaets - Kinderklinik Wuerzburg

Würzburg, D-97080, Germany

Location

Centro di Riferimento Oncologico - Aviano

Aviano, 33081, Italy

Location

Istituto Nazionale per lo Studio e la Cura dei Tumori

Naples, 80131, Italy

Location

Azienda Ospedaliera di Padova

Padua, 35128, Italy

Location

Universita di Siena

Siena, 53100, Italy

Location

Leiden University Medical Center

Leiden, 2300 RC, Netherlands

Location

Daniel Den Hoed Cancer Center at Erasmus Medical Center

Rotterdam, 3008 AE, Netherlands

Location

Hospital Clinic de Barcelona

Barcelona, 08036, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Saint Bartholomew's Hospital

London, England, EC1A 7BE, United Kingdom

Location

Christie Hospital NHS Trust

Manchester, England, M20 4BX, United Kingdom

Location

Related Publications (4)

• 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.

  RESULT

• 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.

  RESULT

• 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.

  PMID: 23715572 DERIVED

• 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.

  PMID: 23715562 DERIVED

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Willem H. J. Kruit, MD, PhD

  Daniel Den Hoed Cancer Center at Erasmus Medical Center

  STUDY CHAIR

• Cornelis J. A. Punt, MD, PhD

  Universitair Medisch Centrum St. Radboud - Nijmegen

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2004
• First Posted: July 12, 2004
• Study Start: May 1, 2004
• Primary Completion: January 1, 2007
• Last Updated: February 10, 2015

Record last verified: 2015-02

Locations

GB (2); BE (2); DE (3); FR (6); IT (4); ES (2); NL (2)