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)

Nantes University Hospital (NUH)

Status and phase

Terminated

Phase 2

Phase 1

Conditions

Metastatic Melanoma

Treatments

Other: TIL-Ad-INFg

Study type

Interventional

Funder types

Other

Identifiers

NCT01082887

BRD/09/05-R

2009-013087-38 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

18 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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