A Study of Immunotherapy With TIL (Tumor Infiltrating Lymphocytes) in Combination With Intra-tumoral Injections of Interferon Gamma-adenovirus (Ad-IFNg) in Patients With Stage IIIc or Stage IV Metastatic Melanoma (AJCC)(Protocol TIL-Ad-INFg)
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Nantes University Hospital
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
Negative viral serology (HIV ½, p24 Ag, HTLV 1 / 2, B and C hepatitis)
You may not be if
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
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
Clareo Health | A Study of Immunotherapy With TIL (Tumor Infiltrating Lymphocytes) in Combination With Intra-tumoral Injections of Interferon Gamma-adenovirus (Ad-IFNg) in Patients With Stage IIIc or Stage IV Metastatic Melanoma (AJCC)(Protocol TIL-Ad-INFg)
