TerminatedPhase 1/2

Immunotherapy of HLA-A2 Positive Stage II-IV Melanoma Patients

Stopped: Low enrollment rate

Switzerland16 participantsStarted 2010-06

Plain-language summary

The purpose of this study is to determine whether vaccination with tumor antigenic peptides and both IMP321/LAG-3 and Montanide adjuvants can induce an immune response in melanoma patients and to assess the safety and tolerability of this vaccination. Tumor responses following this vaccination will also be documented.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Histologically confirmed stage II, III or IV melanoma patients. * Tumor expression of Melan-A. * Human leukocyte antigen-A2 (HLA-A2) positive. * Expected survival of at list 3 months. * Karnofsky scale performance status of 70 % or more. * Age ≥ 18 years. * Able to give a written informed consent. * The following laboratory results: Hemoglobin ≥ 100g/L, Neutrophil count ≥ 1.5 x 109/L, Lymphocyte count ≥ 0.5 x 109/L, Platelet count ≥ 100 x 109/L, Serum creatinine ≤ 2 mg/dL (0.18mmol/L), Serum bilirubin ≤ 2mg/dL (0.034mmol/L), Granulocyte count \> 2.5x109/L, Aspartate Amino Transférase (ASAT), Alanine Amino Transferase (ALAT) \< 2.5 x upper limit of normal, Activated Partial Thromboplastin Time (aPTT) within the normal ranges ±25%, Thromplastin (TP) ≥ 80% Exclusion Criteria: * Clinically significant heart disease. * Serious illness, eg. serious infections requiring antibiotics, uncontrolled peptic ulcer, or central nervous system disorders. * History of immunodeficiency disease or autoimmune disease. * Metastatic disease to the central nervous system, unless treated and stable. * Known HIV positivity. * Known seropositivity for hepatitis B surface antigen. * Concomitant treatment with steroids, antihistamine drugs. Topical or inhalation steroids are permitted. * Participation in any other clinical trial involving another investigational agent within 4 weeks prior to enrollment. * Pregnancy or lactation. * Women of childbearing potential not using a med…

What they're measuring

Ex Vivo Frequency of Melan-A Specific CD8+T Cells

Timeframe: Melan-A specific CD8+ T cells were measured in PBMC collected at the end of Cycle 1 (Week 7), end of Cycle 2 (Week 25), end of Cycle 3 (Week 40), and Follow-up (6 to 18 months after the end of Cycle 3).

In Vitro Frequency of MAGE A3.DP4-specific CD4+ T Cells Producing Interferon-gamma (IFN-γ)

Timeframe: MAGE A3.DP4 specific CD4+ T cells producing IFN-γ were measured in PBMC collected at the end of Cycle 1 (Week 7), end of Cycle 2 (Week 25), end of Cycle 3 (Week 40), and Follow-up (6 to 18 months after the end of Cycle 3).

In Vitro Frequency of MAGE A3.DP4-specific CD4+ T Cells Producing Tumor Necrosis Factor-alpha (TNF-α)

Timeframe: MAGE A3.DP4 specific CD4+ T-cells producing TNF-α were measured in PBMC collected at the end of Cycle 1 (Week 7), end of Cycle 2 (Week 25), end of Cycle 3 (Week 40), and Follow-up (6 to 18 months after the end of Cycle 3).

In Vitro Frequency of MAGE A3.DP4-specific CD4+ T Cells

Timeframe: MAGE A3.DP4 specific CD4+ T cells were measured in PBMC collected at the end of Cycle 1 (Week 7), end of Cycle 2 (Week 25), end of Cycle 3 (Week 40) and Follow-up (6 to 18 months after the end of Cycle 3).

In Vitro Frequency of Melan-A-specific CD8+T Cells After Stimulation

Timeframe: In vitro stimulated Melan-A specific CD8+ T cells were measured in PBMC collected at the end of Cycle 1 (Week 7), end of Cycle 2 (Week 25), end of Cycle 3 (Week 40) and Follow-up (6 to 18 months after the end of Cycle 3).

Trial details

NCT IDNCT01308294

SponsorCentre Hospitalier Universitaire Vaudois

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-04

Results submitted2018-02-12

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