Tumor Infiltrating Lymphocytes Adjuvant Therapy of Melanoma

• Status: Completed
• Trial end date: 2012-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nantes University Hospital

Criteria

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 or DGV HIV.

• 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 therapies).

• 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.