metastatic melanoma patients with regional disease (any T
Conditions
Interventions
Product Name: MAGE-3.A1
Product Code: MAGE-3.A1
Pharmaceutical Form: Powder for suspension for injection
Product Name: NA17.A2 peptide
Product Code: NA17.A2
Pharmaceutical Form: Powder for suspension
Sponsors
Centre du Cancer
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with histologically proven cutaneous melanoma at one of the following AJCC stages (see appendix A) : - Regional metastatic disease (any T; N2c or N3; M0). - Distant metastatic disease (any T; any N; M1a, M1b or M1c*). *except except uncontrolled and brain metastasis. HLA-A1 or HLA-A2 (by serology or molecular biology). MAGE-3 gene expression by the tumour if patient is HLA-A1 and/or NA17 gene expression by the tumour if patient is HLA-A2 (determined by RT-PCR analysis). Patients must have at least two metastases at study entry, including one cutaneous metastasis (equal to or greater than 5 mm in its longest diameter), and one measurable metastasis, as defined by RECIST (see Appendix H and section 3.1 for RECIST v1.1 guidelines, and related deviations). Age = 18 years. Karnosky Performance status (KPS) =70 or WHO performance status of 0 or 1 (see Appendix B). Expected survival of at least 6 months. Normal laboratory values : Platelet count =100x103/µL Leucocyte count = 3x103/µL Hemoglobin = 9 g/dL ASAT and ALAT = 2xUNL Serum creatinine =1.5xUNL Total bilirubin = 1.5xUNL LDH = 1.5xUNL Viral serology : negative antibodies for HCV & HIV; negative antigens for HBV. Patient should agree to perform biopsies and blood collections for translational research. Signed informed consent from the patient or legal representative must be obtained. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Uncontrolled brain or central nervous system metastases. Previous treatment for the melanoma within 6 weeks from inclusion, with any reagent known to modulate the immune system such as a cancer vaccine, interferon-alpha, interleukins or anti-CTLA-4 antibodies. Previous chemotherapy, radiotherapy, corticotherapy, or other immune suppressive therapy within 4 weeks from inclusion. Clinically significant cardiovascular disease (including cardiac insufficiency NYHA grade III and IV, unstable angina, arrythmia, myocardial infarction, symptomatic congestive heart failure) in the past 12 months before enrollment. Other serious acute or chronic illnesses, e.g. active infections requiring antibiotics, bleeding disorders or other conditions requiring concurrent medications not allowed during this study. Other malignancy within 3 years prior to entry in the study, except for treated non-melanoma skin cancer and in situ cervical carcinoma. Active immunodeficiency disease or autoimmune disease (Vitiligo is not an exclusion criterion). Lack of availability for immunological and clinical follow-up assessments. Participation in any other clinical trial involving another investigational agent within 4 weeks prior to enrollment. Subject pregnant or breastfeeding, or planning to become pregnant within 6 months after the end of treatment. Subject (male or female) not willing to use highly effective methods of contraception (per institutional standard) during treatment and for 6 months after the end of treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1) To determine whether peptide vaccination associated with local peritumoral treatment with a combination of interleukin-2, interferon-alpha, granulocyte-macrophage colony stimulating factor, and imiquimod, induces tumor responses.;Secondary Objective: 1) To document whether the toxicity of treatment 2) To document whether this association induces cytolytic T lymphocyte responses to the vaccine antigens. ;Primary end point(s): Tumor response will be assessed in accordance with the Modified RECIST version 1.1 | — |
Countries
Belgium
Outcome results
None listed