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)

Nantes University Hospital1 site in 1 country18 target enrollmentJanuary 2010

ConditionsMetastatic Melanoma

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Metastatic Melanoma
Sponsor: Nantes University Hospital
Enrollment: 18
Locations: 1
Primary Endpoint: Clinical and biological toxicity of combined treatment TIL, IL2 et Ad-INFg
Status: Terminated
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 2010

End Date

October 2012

Last Updated

9 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Nantes University Hospital

Responsible Party

Sponsor

Eligibility Criteria

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:

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

Outcomes

Primary Outcomes

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

Time Frame: 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).