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:
Nantes University Hospital
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
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Metastatic Melanoma |
Other: TIL-Ad-INFg |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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) |
Resource links provided by NLM:
Further study details as provided by Nantes University Hospital:
Primary Outcome Measures:
- 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).
Secondary Outcome Measures:
- 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
| Estimated Enrollment: | 12 |
| Study Start Date: | January 2010 |
| Study Completion Date: | October 2012 |
| Primary Completion Date: | October 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: TIL-Ad-INFg |
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.
|
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01082887
Locations
| France | |
| CHU de Nantes | |
| Nantes, France, 44093 | |
Sponsors and Collaborators
Nantes University Hospital
Investigators
| Principal Investigator: | Brigitte DRENO, Profesor | CHU de Nantes |
| Study Chair: | Gaëlle QUEREUX, Doctor | CHU de Nantes |
| Study Chair: | Anabelle BROCARD, Doctor | CHU de Nantes |
More Information
No publications provided
| Responsible Party: | Nantes University Hospital |
| ClinicalTrials.gov Identifier: | NCT01082887 History of Changes |
| Other Study ID Numbers: | 09/5-R, 2009-013087-38 |
| Study First Received: | March 8, 2010 |
| Last Updated: | January 30, 2013 |
| Health Authority: | France : AFSSAPS |
Keywords provided by Nantes University Hospital:
|
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 |
Additional relevant MeSH terms:
|
Adenoviridae Infections Melanoma DNA Virus Infections Virus Diseases Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms |
Neoplasms, Nerve Tissue Nevi and Melanomas Interferon-gamma Interferons Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Antineoplastic Agents |
ClinicalTrials.gov processed this record on May 19, 2013