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A Phase I/II 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)

Phase 1/Phase 2
18 Years
75 Years
Not Enrolling
Metastatic Melanoma

Thank you

Trial Information

A Phase I/II 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)


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

- 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

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Clinical and biological toxicity of combined treatment TIL, IL2 et Ad-INFg

Outcome Description:

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).

Outcome Time Frame:

12 months

Safety Issue:


Principal Investigator

Brigitte DRENO, Profesor

Investigator Role:

Principal Investigator

Investigator Affiliation:

CHU de Nantes


France : AFSSAPS

Study ID:




Start Date:

January 2010

Completion Date:

October 2012

Related Keywords:

  • Metastatic Melanoma
  • Immunotherapy TIL (Tumor Infiltrating Lymphocytes)
  • Intra-tumoral injection
  • Interferon gamma-adenovirus(Ad-IFNg)
  • Metastatic melanoma
  • A stage IIIc/IV metastatic melanoma with nodal relapse
  • in transit metastasis
  • cutaneous unresectable metastases
  • visceral metastases
  • Adenoviridae Infections
  • Melanoma