Ignite Creation Date:
2024-05-05 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00200577
Status:
COMPLETED
Last Update Posted:
2017-06-01
First Post:
2005-09-12
Brief Title:
Tumor Infiltrating Lymphocytes Adjuvant Therapy of Melanoma
Sponsor:
Nantes University Hospital
Organization:
Nantes University Hospital
Study Overview
Official Title:
TIL Tumor Infiltrating Lymphocytes and IL2 Interleukin 2 Versus Abstention as Adjuvant Treatment in Melanoma With Only One Invaded Lymphnode After Lymphnodes Excision
Status:
COMPLETED
Status Verified Date:
2017-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TIL
Brief Summary:
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
Detailed Description:
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 UI 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None