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

niversity Hospital Tübingen0 sitesNovember 19, 2010

DrugsMultiferon

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Not specified
Sponsor: niversity Hospital Tübingen
Status: Active, not recruiting
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

November 19, 2010

End Date

TBD

Last Updated

12 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

niversity Hospital Tübingen

Eligibility Criteria

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.

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