The main objective of this study is to evaluate the clinical and biologic toxicity of cell
therapy by adoptive transfer of TIL in combination with intra-tumoral injections of Ad-INFg.
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
Pre-Inclusion Criteria:
- Male or female patients ≥ 18 and ≤ 75 years of age
- Patients must have signed informed consent
- A negative pregnancy test for women with childbearing potential
- Patients with stage IIIc/IV metastatic melanoma (AJCC 6th edition) with nodal
relapse, in transit metastasis, unresectable cutaneous metastases, visceral
metastases except bone and brain metastases
- Presence of at least one lesion accessible for intra-tumoral injections of Ad-IFNg
- A negative brain scan, eliminating any brain metastases
- ECOG performance status of 0-2
- Adequate bone-marrow reserve, renal function and hepatic function as assessed by
standard laboratory criteria
- Subjects affiliated to an appropriate social security system
Inclusion Criteria:
- Negative viral serology (HIV ½, p24 Ag, HTLV 1 / 2, B and C hepatitis)
Exclusion Criteria:
- For female : the patient is pregnant or lactating or not using contraception and
proved by a negative pregnancy test
- Positive viral serology for HIV ½, p24 Ag, HTLV 1 / 2 or B and C hepatitis
- History or current manifestations of severe progressive heart disease (congestive
heart failure, coronary artery disease, uncontrolled arterial hypertension, serious
rhythm disorders or ECG signs of previous myocardial infarction)
- Any serious illness, acute or chronic, e. g. active infection requiring antibiotics,
bleeding disorders or any other condition that requires concomitant medications not
allowed during this study
- Presence of a second active cancer except in situ cervical cancer or skin carcinoma
- Intercurrent disease requiring a corticosteroid treatment or a treatment with
interferon-α
- Any autoimmune disease including active diabetes mellitus or immunodeficiency.
Vitiligo in not an exclusion criteria
- Uncontrolled thyroid dysfunction
- Concurrently participation in a biomedical research (drug or radiotherapy) within the
month preceding inclusion
- Metastatic lymph node stage alone with an indication of lymphadenectomy
- Brain or bone metastases discovered by radiological examination during the inclusion
assessment
- Surgically resectable metastases
- Ocular melanoma
- More than one line of chemotherapy for treatment of melanoma
- Chemotherapy, immunotherapy or radiotherapy within 4 weeks before baseline (6 weeks
for nitroso-ureas and mitomycin C)
- Contraindication for the use of vasopressor agents
- Treatment with molecules in pre-marketing development or whose development is
finished less than 4 weeks