The objective of this multicentric Phase III study is to confirm the results of the phase I-II study (Dreno B \& Al. Cancer Immunol Immunother 2002; 51: 539-456) which demonstrated the preventive effect of a treatment by TIL (Tumor Infiltrating Lymphocytes) combined with IL2 (Interleukin 2; low dose injected subcutaneously) on the metastatic relapse in the stage III melanoma patients with only one invaded lymphnode.
In this open, multicentric (Grenoble, Montpellier, Nantes, Angers, Caen, Le Mans, Poitiers, Rennes, Tours) randomized study, selected patients with only one invaded lymphnode confirmed by anatomopathological exam will be randomized to one of the following arms: 1-Control group: patients of this group will not receive any treatment and will have the same clinical follow-up as the treated group. 2- TIL-IL2 group: treated patients will receive two injections of TIL combined with IL2. Tumor Infiltrating Lymphocytes will be obtained from a small piece of tumour tissue removed from the invaded lymphnode after surgery. TIL will be grown in larger number in laboratory during 6 weeks. Patients randomized in treatment arm will receive two injection of TIL (the first about 6 and the second about 10 weeks post-surgery). Administration of TIL will be combined with a low dose of IL2 (6 million U.I. per day) injected subcutaneously from J1 to J5 and J8 to J12 following the day of TIL infusion. The same dose and duration of IL2 treatment will be used for the second injection of TIL performed one month later. After 2 months adjuvant therapy, patients received no other treatment. Only a regular follow-up was performed.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
70
Patients are treated with 2 injections Of TIL (1st injection M1 and the second M2)The received concomitant IL2 at M1 and M2 on days Jo (injection TIL) to J5 and J8 to J12
CHU Angers
Angers, France
CHU Caen
Caen, France
Grenoble University Hospital
Grenoble, France
CH Le Mans
Le Mans, France
Determination of the duration of the relapse-free interval.
Time frame: 5 years
Physical examination, every 2 months until M18 then every 3 months until M36 then every 4 months up to 5 years, then once per year with a clinical examination only.
Time frame: every 2 months until M18then every 3 months until M36 then every 4 months up to 5 years
Abdominal echography will be performed at the screening visit, M4, M8, M12 and then every 6 months until 5ans.
Time frame: M4, M8, M12 and then every 6 months until 5ans.
CT-Scan will be performed before the first administration of study treatment (at the time of screening visit), every 6 months during 2 years and then every years up to 5 years.
Time frame: every 6 months during 2 years and then every years up to 5 years.
Determine of overall survival
Time frame: 5 years
To define safety and toxicity of TIL/IL2 treatment
Time frame: 5 years
Evaluation of immunological responses
Time frame: M0, J56, M12
Analysis of the clinical, biological and histological factors on the survival of the patients
Time frame: at inclusion and each month
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Montpellier University Hospital
Montpellier, France
Nantes University Hospital
Nantes, France
CHU Poitiers
Poitiers, France
CHU Rennes
Rennes, France
CHRU Tours
Tours, France