Subcutaneous administration of Interleukin-2 prior to surgical intervention in case of sonographically and cytologically involved sentinel node

• Conditions: The trial is planned in a neo-adjuvant setting for a 4-weeks period in Melanoma patients with stage III. The stage is to be discovered by ultrasound and veriefied by fine needle punctere and cytology.; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2011-001474-25-DE
• Lead Sponsor: Klinik für Dermatologie, Venerologie und Allergologie; Charité - Universitätsmedizin Berlin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09-20
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Inclusion criteria
1. Informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject.)
2. Confirmed (by histology of the primary and FNAC/cytology of the involved lymph node) stage III malignant melanoma according to the American Joint Committee on Cancer (AJCC 2009) within the following classification:
a. T1-4b
b. N1-3 (assessed by high resolution ultrasound and FNAC)
c. M0
3. At least one lymph node with only partially malignant involvement as assessed by ultrasound
4. 18 years of age or above
5. ECOG performance status of 0 or 1
6. Hematology:
a. White blood cell (WBC) = 2.5 x 109/L
b. Absolute neutrophil count (ANC) = 1.5 x 109/L
c. Platelet count = 100 x 109/L
d. Hemoglobin = 100 g/L
7. Serum-creatinine = 1.8 mg/dL
8. Liver function:
a. ALT and Alkaline Phosphatase = 2.5 x upper limit of normal (ULN)
b. LDH = 2 x ULN
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

Exclusion criteria
1. Known or suspected allergy to trial product(s) or related products
2. Any contraindication as listed in the product label for IL-2 (Proleukin®, Aldesleukin)
3. Previous participation in this trial. (Participation is defined as screening)
4. Any signs of stage IV disease according to AJCC 2009 as assessed by routine radiographic staging5. Prior wide excision of the primary lesion, which in the opinion of the investigator may alter lymphatic flow to the sentinel lymph nodes
6. Bulky lymph nodes metastases, which in the opinion of the investigator may completely obstruct lymphatic flow to the regional lymph nodes, as assessed by ultrasound
7. Clinically significant infection in the area of the primary tumour
8. Documented positive serologic testing for hepatitis B or C
9. History of or active presence of auto-immune diseases (except vitiligo and treated pernicious anemia)
10. History of any other active malignancy incl. ocular malignant melanoma (except basal cell carcinoma of the skin and cervical cancer in situ) within 5 years of enrolment
11. Cardiac disease within the last 12 months defined as:
a) decompensated heart failure (New York Heart Association (NYHA) class III or IV)
b) unstable angina pectoris
c) serious arrhythmias
d) myocardial infarction
12. Concurrent treatment with systemic corticosteroids or other immunosuppressive drugs (topical or inhaled corticosteroid treatment is permitted)
13. Known chronic infectious disease including human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS) related illness
14. Any significant systemic disease which according to the Investigator could compromise the safety of the subject or interfere with the trial objectives
15. Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods (adequate contraceptive measures are implants, injectables, combined oral contraceptives, hormonal IUD, barrier methods, sexual abstinence or vasectomised partner)
16. The receipt of any investigational drug within 3 months prior to this trial
17. Location of the primary lesion where multiple injections of s.c. IL-2 are not feasible

Study & Design

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