A single arm, single-centre, open-label, exploratory trial of recombinant Interleukin-21 administered subcutaneously for 4 weeks as neo-adjuvant treatment prior to sentinel lymph node/complete lymph node dissection followed by 8 weeks of adjuvant treatment in subject with stage III malignant melanoma

• Conditions: Recombinant Interleukin-21 administered subcutaneously for 4 weeks as neo-adjuvant treatment prior to sentinel lymph node/complete lymph node dissection followed by 8 weeks of adjuvant treatment in subject with stage III malignant melanoma; MedDRA version: 9.1Level: LLTClassification code 10025670Term: Malignant melanoma stage III

• Registration Number: EUCTR2006-005350-79-DE
• Lead Sponsor: ovo Nordisk A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07-22
• Last Update Posted: 24 April 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 20

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 histologically stage III malignant melanoma according to the American Joint Committee on Cancer (AJCC 2006) within the following classification:
-T1-4b
-N1-3 (assessed by high resolution ultrasound)
-M0
3.At least one lymph node with only partial malignant involvement as assessed by ultrasonography
4.18 years of age or above
5.ECOG performance status of 0 or 1
6.Haematology:
-White blood cell (WBC) = 2.5 x 10^9/L
-Absolute neutrophil count (ANC) = 1.5 x 10^9/L
-Platelet count = 100 x 10^9/L
-Haemoglobin = 100 g/L
7.S-creatinine = 1.8 mg/dL
8.Liver function:
-ALT and Alkaline Phosphatase = 2.5 x upper limit of normal (ULN)
-LDH = 2 x ULN

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

1.Known or suspected allergy to trial product(s) or related products
2.Previous participation in this trial. Participation is defined as screening
3.Any signs of stage IV disease according to AJCC 2006 as assessed by routine radiographic staging
4.Prior wide excision of the primary lesion
5.Bulky lymph nodes metastases larger than 2 cm in longest diameter as assessed by ultrasonography
6.Clinically significant infection in the area of the primary tumour
7.Documented positive serologic testing for hepatitis B or C
8.History of or active presence of auto-immune diseases (except vitiligo and treated pernicious anaemia)
9.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
10.Cardiac disease within the last 12 months defined as:
-decompensate heart failure (New York Heart Association (NYHA) class III or IV)
-serious arrhythmias
-unstable angina pectoris
-myocardial infarction
11.Concurrent treatment with systemic corticosteroids or other immunosuppresive drugs (topical or inhaled corticosteroid treatment is permitted)
12.Known chronic infectious disease including human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS) related illness
13.Any significant systemic disease which according to the Investigator could compromise the safety of the subject or interfere with the trial objectives
14.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, sexual abstinence, or vasectomised partner)
15.The receipt of any investigational drug within 3 months prior to this trial
16.Location of the primary lesion where multiple injections of rIL-21 are not possible

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To estimate the complete response rate of the sentinel lymph node(s) as assessed by histopathology in subjects with stage III malignant melanoma measured after 4 weeks of local neo-adjuvant treatment with recombinant interleukin-21 (rIL-21). ;Primary end point(s): •Complete pathological response rate defined as the percentage of subjects identified with lack of detectable malignant disease in the dissected sentinel lymph nodes after a 4-week neo-adjuvant rIL-21 treatment period and assessed according to the EORTC Melanoma Group protocol for SLN examination.;Secondary Objective: To describe the immune modulating effects of rIL-21 within the tumour draining lymph nodes and the peripheral blood.<br>-To estimate relapse free servival.<br>-To describe the safety of neo-adjuvant and adjuvant subcutaneous (s.c) administration of rIl-21 in subjects with stage III malignant melanoma<br>-To assess if antibodies against rIL-21 are induced during therapy