A phase II study of L19IL2 injected directly into the tumor in patients with stage III/IV melanoma

• Conditions: Cancer- Patients with histopathologically-proven malignant melanoma with presence of measurable and injectable dermal or subcutaneous metastases either in clinical stage III or stage IV; MedDRA version: 14.0Level: PTClassification code 10025671Term: Malignant melanoma stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 14.0Level: PTClassification code 10025670Term: Malignant melanoma stage IIISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2009-014799-23-DE
• Lead Sponsor: Philogen S.p.A

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08-18
• Last Update Posted: 26 November 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 40

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 and platelets > 100 x 109/L
•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 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

•Primary ocular melanoma
•Presence of visceral metastases at screening
•Evidence of active brain metastases at screening.
•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.
•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)
•Active autoimmune disease
•History of organ allograft or stem cell transplantation
•Known history of allergy to IL2, or other intravenously administered human proteins/peptides/antibodies.
•Breast feeding female
•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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified