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TIL (Tumor Infiltrating Lymphocytes) and IL2 (Interleukin 2) Versus Abstention as Adjuvant Treatment in Melanoma With Only One Invaded Lymphnode After Lymphnodes Excision

Phase 3
75 Years
Not Enrolling

Thank you

Trial Information

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.

Inclusion Criteria:

- Melanoma stage III (regional lymph node recurrence). Will be selected the patients
with only one invaded lymph node confirmed by anatomopathological exam after lymph
nodes excision.

- Absence of visceral metastases verified by physical examination, chest radiography,
liver echography and brain-chest-liver CT-Scan.

- Age < 75 years, both genders

- ECOG 0-2, Karnofsky > 80%.

- Negative pregnancy test performed at the screening visit for fertile women.

- The potentially fertile women must use an oral contraception or an intra-uterine
device (IUD) until three months following the last injection of the study treatment.

- The patients must have fully recovered from surgery.

- HIV 1/2: The patients must be negative for antibodies HIV 1 and HIV 2 and for Ag P24

- HBV: The patients must be negative for the antigen, but can be positive for the
antibodies but with a negative DNA PCR.

- HCV: The patients must be negative for the antibodies.

- HTLV ½: The patients must be negative for the antibodies.

- Following laboratory results:

- Hemoglobin: ≥ 10 g/dl

- WBC: ≥ 4000/µl

- Lymphocytes: ≥ 700/µl

- Platelet count: ≥ 100.000/µl

- Serum creatinine: < 2.0 mg/dl or £ 177 mmol/l

- Serum Bilirubin: < 2.0 mg/dl or £ 34.2 mmol/l

- ASAT and ALAT: < 2.5 x the upper limit of normal.

Exclusion criteria:

- Patient with more than one invaded lymph node confirmed by anatomopathological exam.

- Presence of melanoma metastases discovered by clinical or radiological examination at
the screening visit.

- Patients must not have received any Chemotherapy, immunotherapy or radiotherapy
within the preceding 4 weeks (6 weeks since prior nitrosurea and mitomycin C

- Presence of cardiac affections (congestive cardiac insufficiency, coronaropathy, not
controlled HTA).

- Any serious active medical illnesses, for example: Active systemic infections
requiring of antibiotics, coagulation disorders or any other condition which requires
concomitant medications not allowed during this study.

- Presence of the second active cancer other than surgically cured non-melanoma skin
cancer or cervical carcinoma in-situ.

- Any affection requiring a systemic corticotherapy or a treatment by Interferon A.

- Any active auto-immune disease including the insulin-dependent diabetes or a
immunodeficiency. The vitiligo is not an exclusion criteria.

- Thyroid dysfunction not responsive to therapy.

- Positive Serology for HIV, HVB, HVC or HTLV1/2.

- Woman pregnant or nursing or without an effective contraception.

- Incapacity to give written consent.

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determination of the duration of the relapse-free interval.

Outcome Time Frame:

5 years

Safety Issue:


Principal Investigator

Brigitte DRENO, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Nantes University Hospital


France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:




Start Date:

May 2005

Completion Date:

December 2012

Related Keywords:

  • Melanoma
  • Adjuvant therapy
  • immunotherapy
  • TIL
  • melanoma
  • Melanoma