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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)

Information source: Nantes University Hospital
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Metastatic Melanoma

Intervention: TIL-Ad-INFg (Other)

Phase: Phase 1/Phase 2

Status: Terminated

Sponsored by: Nantes University Hospital

Official(s) and/or principal investigator(s):
Brigitte DRENO, Profesor, Principal Investigator, Affiliation: CHU de Nantes
Gaëlle QUEREUX, Doctor, Study Chair, Affiliation: CHU de Nantes
Anabelle BROCARD, Doctor, Study Chair, Affiliation: CHU de Nantes

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.

Clinical Details

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)

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

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

Secondary outcome:

Objective response rate

Tumoral response

Progression-free survival

Overall survival

Immunological response

Eligibility

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

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

Locations and Contacts

CHU de Nantes, Nantes 44093, France
Additional Information

Starting date: January 2010
Last updated: June 11, 2013

Page last updated: August 20, 2015

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