Status:
TERMINATED
Immunization of Disease-Free Melanoma Patients With Different HLA-A2 Peptides
Lead Sponsor:
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Collaborating Sponsors:
Immutep S.A.S.
Conditions:
Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
Open-label single center study. Patients will be divided in four groups of 7. Group 1: 8 melanoma-specific peptides in saline; Group 2: same mix of peptides + Montanide ISA51; Group 3: same mix of pep...
Detailed Description
Open-label single center study. Patients will be divided in four groups of 7. The patients will be entered sequentially at the time they present in clinic, and randomized in one of the four groups. T...
Eligibility Criteria
Inclusion
- Histologically proven cutaneous melanoma.
- Patient's melanoma must be in one of the following AJCC stages :
- only primary tumor : T3b-T4, N0, M0. regional lymph node metastasis and/or in-transit metastasis, no distant metastasis (any T, N1-N3, M0) that has been removed.
- Any distant metastasis that has been removed (M1) HLA-A2 positive. Patients with previous regional metastatic disease must have one of their resected lesions analyzed by RT-PCR to determine expression of genes MAGE-1, MAGE-3, MAGE-4, MAGE-10, MAGE-C2, NA17, Tyrosinase or NY-ESO-1. However, expression of these genes by the tumor is not required to enter the study.
- Absence of detectable melanoma lesions. WHO/ECOG performance status of 1 or less (Karnofsky scale ≥ 70%).
- The following laboratory results:
- Hemoglobin ≥ 10 g/dl; Neutrophils ≥ 1,500/µl; Lymphocytes ≥ 700/µl; Platelets ≥ 100,000/µl; Serum creatinin ≤ 2.0 mg/dl; Serum bilirubin ≤ 2.0 mg/dl; LDH within normal institutional limits.
- Age \> 18 years. Able to give written informed consent.
Exclusion
- Clinically significant heart disease (NYHA Class III or IV). Other serious illnesses, e.g. serious infections requiring antibiotics, bleeding disorders, a second active malignancy, except basal cell carcinoma or in situ carcinoma of the uterine cervix.
- Active immunodeficiency disease or autoimmune disease. Positive serology for HIV (human immunodeficiency virus) or HCV (hepatitis C virus). Serum hepatitis B antigen (HBsAg) must be negative.
- More than one line of previous chemotherapy, or immunotherapy for the melanoma. Previous vaccination with one of the antigen present in the vaccine. Treatment with steroids or major immunosuppressive drugs within 4 weeks before study entry. Topical or inhalational 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 medically acceptable means of contraception.
- Psychiatric or addictive disorders that may compromise the ability to give informed consent.
- Lack of availability of the patient for immunological and clinical follow-up assessment.
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 13 2013
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT00365937
Start Date
August 1 2006
End Date
December 13 2013
Last Update
March 6 2019
Active Locations (1)
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1
Cliniques Universitaires Saint-Luc
Brussels, Belgium, 1200