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)
Phase 1
Terminated
- Conditions
- Metastatic Melanoma
- Interventions
- Other: TIL-Ad-INFg
- Registration Number
- NCT01082887
- Lead Sponsor
- Nantes University Hospital
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 18
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description TIL-Ad-INFg TIL-Ad-INFg -
- Primary Outcome Measures
Name Time Method Clinical and biological toxicity of combined treatment TIL, IL2 et Ad-INFg 12 months The evaluation of clinical and biological toxicity of combined treatment including infusion of TIL associated with subcutaneous injections of low-doses of IL-2 and intra-tumoral injections of Ad-IFNg will be performed according to clinical and biological criteria defined by NCI (Common Toxicity Criteria - version 3.0, August 2006).
- Secondary Outcome Measures
Name Time Method Tumoral response 12 months The evaluation of the tumoral response of injected lesions every month
Objective response rate 12 months The evaluation of the objective response rate
Overall survival 12 months The evaluation of the overall survival
Immunological response 12 months The evaluation of the immunological response
Progression-free survival 12 months The evaluation of the progression-free survival,
Trial Locations
- Locations (1)
CHU de Nantes
🇫🇷Nantes, France