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)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Nantes University Hospital

ClinicalTrials.gov Identifier:

NCT01082887

First received: March 8, 2010

Last updated: January 30, 2013

Last verified: January 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

March 8, 2010

Last Updated Date

January 30, 2013

Start Date ^ICMJE

January 2010

Primary Completion Date

October 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Clinical and biological toxicity of combined treatment TIL, IL2 et Ad-INFg [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

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).

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01082887 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Objective response rate [ Time Frame: 12 months ] [ Designated as safety issue: No ]
The evaluation of the objective response rate
Tumoral response [ Time Frame: 12 months ] [ Designated as safety issue: No ]
The evaluation of the tumoral response of injected lesions every month
Progression-free survival [ Time Frame: 12 months ] [ Designated as safety issue: No ]
The evaluation of the progression-free survival,
Overall survival [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
The evaluation of the overall survival
Immunological response [ Time Frame: 12 months ] [ Designated as safety issue: No ]
The evaluation of the immunological response

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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)

Official Title ^ICMJE

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)

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1
Phase 2

Study Design ^ICMJE

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

Condition ^ICMJE

Metastatic Melanoma

Intervention ^ICMJE

Other: TIL-Ad-INFg

After verification of inclusion and non-inclusion criteria and after obtaining informed consent from the patients, a tumor sample will be taken for sterile production of TIL. Patients will receive intra-tumoral injections of Ad-INFg every 15 days from J-15 to M2, then every month from M3 to M11 or until disease progression. The Ad-INFg will be administered by intra-tumoral injection at a dose of 5x1010 vp (viral particles) per lesion. A maximum of 6 lesions will be treated simultaneously. They will also receive two infusion of TIL at M0 (Cycle 1) and M1 (Cycle 2) by intravenous infusion lasting 30 to 65 minutes followed by subcutaneous injections of IL2 from J1 to J5 and from J8 to J12 of each cycle.An evaluation of injected and not injected tumoral lesions including photographs will be realised at the pre-inclusion visit, J-15, M0 and every month until M12.

Study Arm (s)

Experimental: TIL-Ad-INFg

Intervention: Other: TIL-Ad-INFg

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

October 2012

Primary Completion Date

October 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

France

Administrative Information

NCT Number ^ICMJE

NCT01082887

Other Study ID Numbers ^ICMJE

09/5-R, 2009-013087-38

Has Data Monitoring Committee

Yes

Responsible Party

Nantes University Hospital

Study Sponsor ^ICMJE

Nantes University Hospital

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:	Brigitte DRENO, Profesor	CHU de Nantes
Study Chair:	Gaëlle QUEREUX, Doctor	CHU de Nantes
Study Chair:	Anabelle BROCARD, Doctor	CHU de Nantes

Information Provided By

Nantes University Hospital

Verification Date

January 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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