TIL (Tumor Infiltrating Lymphocytes) and IL2 (Interleukin 2) Versus Abstention as Adjuvant Treatment in Melanoma With Only One Invaded Lymphnode After Lymphnodes Excision
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.
Interventional
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Determination of the duration of the relapse-free interval.
5 years
No
Brigitte DRENO, MD
Principal Investigator
Nantes University Hospital
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
BRD/04/1-D
NCT00200577
May 2005
December 2012
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