eoadjuvant treatment of locoregional metastases in malignant melanoma (AJCC stage IIIB/C) with Multiferon?: a phase IIa DeCOG trial - NAM-Trial

• Conditions: The study is an open label, multicenter phase IIa clinical trial which is designed as a pilot project in order to establish the efficacy and tolerability of Multiferon? as a neoadjuvant treatment of locoregional metastases.

• Registration Number: EUCTR2010-022103-21-DE
• Lead Sponsor: niversity Hospital Tübingen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11-19
• Last Update Posted: 13 May 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

a)Histologically proven cutaneous melanoma
b)Clinical stage IIIB or IIIC (AJCC 2010)
c)= 18 years of age
d)Presence of at least two metastases, not more than 10 metastases, and completely resectable
e)Measurable disease (at least one lesion that can be accurately measured in two perpendicular diameters, with both dimensions >= 5mm
f)ECOG performance status of 0/1
g)Patients with previous adjuvant recombinant interferon-a treatment of any dose are eligible if (i) treatment was stopped at least 1 month before start of treatment and (ii) no progression occurred during interferon-a treatment.
h)No childbearing potential or negative pregnancy test within 14 days before inclusion in women with child bearing potential
Women with childbearing potential must be using an effective method of contraception (Pearl-Index < 1, e.g. oral contraceptives, other hormonal contraceptives [vaginal products, skin patches, or implanted or injectable products], or mechanical products such as an intrauterine device or barrier methods [diaphragm, spermicides]) throughout the study and for up to 3 months after the last dose of investigational product, in such a manner that the risk of pregnancy is minimized.
No men of fathering potential or men of fathering potential must be using an effective method of contraception to avoid conception throughout the study and for up to 3 months after the last dose of investigational product, in such a manner that the risk of pregnancy is minimized.
i)Signed and dated informed consent informed consent before the start of specific protocol 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

j)Mucous membrane or ocular melanoma
k)Any evidence of distant metastasis (e.g. whole body CT-scan including brain scan within 4 weeks before inclusion)
l)Patients with severe cardiac disease (e.g. NYHA Functional Class III or IV, myocardial infarction within 6 months before inclusion, ventricular tachyarrhythmia requiring ongoing treatment, unstable angina pectoris).
m)ALAT or ASAT > 2 x ULN
n)Total bilirubin > 2 x ULN
o)Creatinine > 2 x ULN
p)Patients who have a history of depression requiring hospitalization
q)Patients with seizure disorders requiring anticonvulsant therapy
r)Any of the following abnormal baseline hematologic/laboratory values:
Hb < 10g/dl
WBC < 3.0x109 /l
Platelets < 100x109 /l
s)Presence of active autoimmune disease
t)Concurrent systemic glucocorticoids or any other systemic immunosuppressive therapy
u)Unwilling or unable to comply with the requirements of the protocol
v)Known infection with HBV, HCV, HIV
w)Pregnant or lactating women
x)Unwillingness or inability to employ an effective barrier method of birth control throughout the study and for up to 3 months after end of treatment in female or male patients

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: Overall response rate (clinical and radiological) after 4 weeks of treatment (CR + PR) according to immune-related response criteria (irRC).;Secondary Objective: - Disease control rate (CR + PR +SD) according to irRC<br>- Rate of histopathological complete responses<br>- Tolerability <br>- Differences in gene expression in metastatic tissue before/after treatment<br>- Dose dependency of effects <br>- Changes of serum markers and PBMC subsets before/after treatment (optional translational side studies)<br>;Primary end point(s): The primary endpoint is the overall response rate (clinical and radiological) after 4 weeks of treatment (CR + PR) according to immune-related response criteria (irRC).