Status:
TERMINATED
Peptide Vaccination Associated With Tumoral Immunomodulation in Patients With Advanced Metastatic Melanoma
Lead Sponsor:
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Conditions:
Metastatic Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
Human cancers express tumor antigens that can be targeted by cytolytic T lymphocytes (CTL). These antigens consist of a small peptide, derived from endogenous proteins, that is presented at the cancer...
Detailed Description
Patients will receive the following treatments: 1. Vaccinations: The vaccine will be the MAGE-3.A1 and/or the NA17.A2 peptide, matching the patient's HLA type and the gene expression of his tumor...
Eligibility Criteria
Inclusion
- 1\. Patients with histologically proven cutaneous melanoma at one of the following AJCC stages.Regional metastatic disease (any T; N2c or N3; M0). Distant metastatic disease (any T; any N; M1a, M1b or M1c\*).\*except uncontrolled brain metastasis.
- 2\. HLA-A1 or HLA-A2 (by serology or molecular biology).
- 3\. MAGE-3 gene expression by the tumor if patient is HLA-A1 and/or NA17 gene expression by the tumor if patient is HLA-A2 (determined by RT-PCR analysis).
- 4\. Measurable Disease (RECIST v1.1)Patients must have at least 2 cutaneous metastases, suitable for peri-tumoral injection and surgical resection, with their largest diameter equal to or greater than 5 mm.
- 5\. Age ≥ 18 years.
- 6\. Karnosky Performance status (KPS) ≥70 or WHO performance status of 0 or 1
- 7\. Expected survival of at least 6 months.
- 8\. 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
- 9\. Viral serology : negative antibodies for HCV \& HIV; negative antigens for HBV.
- 10\. Patient should agree to perform biopsies and blood collections for translational research.
- 11\. Signed informed consent from the patient or legal representative must be obtained.
Exclusion
- 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.
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT01191034
Start Date
August 1 2010
End Date
August 1 2012
Last Update
March 12 2019
Active Locations (1)
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1
Cliniques Universitaires Saint-Luc
Brussels, Belgium, 1200