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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	EUCTR
Last refreshed on:	30 September 2013
Main ID:	EUCTR2009-014799-23-IT
Date of registration:	09/06/2010
Prospective Registration:	Yes
Primary sponsor:	PHILOGEN S.P.A.
Public title:	A phase II study of intratumoral application of L19IL2 in patients with stage III/IV melanoma - Intratumoral application of L19IL2 in patients with malignant melanoma
Scientific title:	A phase II study of intratumoral application of L19IL2 in patients with stage III/IV melanoma - Intratumoral application of L19IL2 in patients with malignant melanoma
Date of first enrolment:	26/07/2010
Target sample size:	30
Recruitment status:	Not Recruiting
URL:	https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-014799-23
Study type:	Interventional clinical trial of medicinal product
Study design:	Controlled: no Randomised: no Open: no Single blind: no Double blind: no Parallel group: no Cross over: no Other: yes Other trial design description: Studio di fase II, non randomizzato, multicentrico e prospettico If controlled, specify comparator, Other Medicinial Product: Placebo: Other:
Phase:

Countries of recruitment
Austria	Germany	Italy

Contacts

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Affiliation:

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Key inclusion & exclusion criteria

Inclusion criteria:
• Histopathologically proven malignant melanoma
• Presence of measurable and injectable soft tissue metastases either in clinical stage III or stage IV M1a without visceral metastases.
• Males or females, age > 18 years
• Either without or after one line of prior systemic treatment for metastatic disease.
• ECOG performance status < 2
• LDH < 2 x the upper limit of normal
• Life expectancy of at least 12 weeks
• Absolute neutrophil count > 1.5 x 109/L
• Hemoglobin > 9.0 g/dL
• Platelets > 100 x 109/L
• Total bilirubin = 30 ?mol/L (or = 2.0 mg/dl)
• ALT and AST = 2.5 x the upper limit of normal (ULN) (5.0 x ULN for patients with hepatic involvement with tumor)
• Serum creatinine < 1.5 x ULN
• All acute toxic effects (excluding alopecia) of any prior therapy must have resolved to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) (v4.02) Grade = 1 unless otherwise specified above
• Negative serum pregnancy test (for women of child-bearing potential only) at screening
• If of childbearing potential, agreement to use adequate contraceptive methods (e.g., oral contraceptives, condoms, or other adequate barrier controls, intrauterine contraceptive devices, or sterilization) beginning at the screening visit and continuing until 3 months following last treatment with study drug.
• Able to provide written Informed Consent.
• Willingness and ability to comply with the scheduled visits, treatment plan, laboratory tests and other study procedures.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
• Primary ocular melanoma
• Presence of visceral metastases at screening
• Evidence of active brain metastases at screening.
• Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study except cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (TA, Tis & Ti) or any cancer curatively treated < 5 years prior to study entry
• History of HIV infection or infectious hepatitis B or C
• Presence of active infections (e.g. requiring antimicrobial therapy) or other severe concurrent disease, which, in the opinion of the investigator, would place the patient at undue risk or interfere with the study.
• History within the last year of acute or subacute coronary syndromes including myocardial infarction, unstable or severe stable angina pectoris.
• Inadequately controlled cardiac arrhythmias including atrial fibrillation
• Heart insufficiency (> Grade II, New York Heart Association (NYHA) criteria)
• Uncontrolled hypertension
• Ischemic peripheral vascular disease (Grade IIb-IV)
• Severe diabetic retinopathy.
• Active autoimmune disease
• History of organ allograft or stem cell transplantation
• Recovery from major trauma including surgery within 4 weeks prior to administration of study treatment.
• Known history of allergy to IL2, or other intravenously administered human proteins/peptides/antibodies.
• Breast feeding female
• Anti-tumor therapy within 4 weeks of the administration of study treatment (except small surgery).
• Previous in vivo exposure to monoclonal antibodies for biological therapy in the 6 weeks before administration of study treatment.
• Growth factors or immunomodulatory agents within 7 days of the administration of study treatment
• Patients in need of systemic treatment for rapidly progressive systemic disease during study treatment and up to 2 weeks after injection of L19IL2.
• Patient requires or is taking corticosteroids or other immunosuppressant drugs on a long-term basis. Limited use of corticosteroids to treat or prevent acute hypersensitivity reactions is not considered an exclusion criterion.
• Any conditions that in the opinion of the investigator could hamper compliance with the study protocol.

Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

patients with stage III/IV melanoma
MedDRA version: 9.1 Level: LLT Classification code 10025670
MedDRA version: 9.1 Level: LLT Classification code 10025671

Intervention(s)

Product Name: L19IL2
Pharmaceutical Form: Solution for injection
Current Sponsor code: L19IL2
Concentration unit: million IU million international units
Concentration type: equal
Concentration number: 10-

Primary Outcome(s)

Primary end point(s): Primary endpoints of the study is the rate of patients with complete response (CR) of L19IL2 treated metastases at week 12. A 95% confidence interval will be provided.

Secondary Objective: Safety of intratumoral administration of L19IL2
Rate of patients with CR, partial response (PR) and stable disease (SD) of L19IL2 treated metastases at week 12 (objective response rate and disease control rate of L19IL2 treated metastases)
Duration of objective response and disease control of L19IL2 treated metastases
Rate of patients with CR, PR and SD of all metastases at week 12 (objective response rate and disease control rate of all metastases)
Duration of objective response and disease control of all metastases
Overall survival (OS)
Quality of life

Main Objective: Rate of patients with complete response (CR) of L19IL2 treated metastases at week 12

Secondary Outcome(s)

Secondary ID(s)

PH-L19IL2-03/09

2009-014799-23-DE

Source(s) of Monetary Support

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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