NCT01082887TerminatedPhase 1
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 Hospital2 sites in 1 country18 target enrollmentStarted: January 2010Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Terminated
- Sponsor
- Nantes University Hospital
- Enrollment
- 18
- Locations
- 2
- Primary Endpoint
- Clinical and biological toxicity of combined treatment TIL, IL2 et Ad-INFg
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
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).
Secondary Outcomes
- Tumoral response(12 months)
- Objective response rate(12 months)
- Overall survival(12 months)
- Immunological response(12 months)
- Progression-free survival(12 months)
Investigators
Study Sites (2)
Loading locations...
Similar Trials
Active, not recruiting
Phase 1
ACT-TIL and ANV419 for Advanced Melanoma.Advanced MelanomaNCT05869539University Hospital, Basel, Switzerland10
Terminated
Phase 1
HV-101 for Patients With Advanced Solid TumorsAdvanced Solid TumorsNCT05868915Hervor Therapeutics1
Recruiting
Early Phase 1
A Study of TIL in Advanced Solid Tumors (DFGD)Advanced Solid TumorTumor Infiltrating LymphocytesTreatment Side EffectsEffects of ImmunotherapyNCT06488950Shanghai Juncell Therapeutics30
Recruiting
Phase 1
A Clinical Study on TIL for the Treatment of Advanced Solid TumorsAdvanced Solid TumorTumor Infiltrating LymphocytesTreatment Side EffectsEffects of ImmunotherapyNCT05087745Shanghai Juncell Therapeutics50
Recruiting
Phase 1
A Study of GC101 TIL in Advanced Solid Tumors (TR)Advanced Solid TumorsNCT04967833Shanghai Juncell Therapeutics20