NCT01341158

NAM-Trial: Multiferon in Malignant Melanoma

Neoadjuvant Treatment of Locoregional Metastases in Malignant Melanoma (AJCC Stage IIIB/C) With Multiferon: a Phase IIa DeCOG Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: University Hospital Tuebingen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The current clinical trial shall clarify the efficacy, safety and biologic effects of neoadjuvant treatment with natural interferon-α (Multiferon) in patients with locoregional metastases of melanoma in stage IIIB/C.

Detailed description

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. Patients will be treated subsequently in cohorts characterized by different doses (3 - 9 - 18 MIU) to analyze dosage dependent effects.

Conditions

• Locoregional Metastases in Malignant Melanoma Stages IIIB/C

Interventions

Type	Name	Description
DRUG	human interferon-α	Neoadjuvant treatment: Multiferon is given as flat dosages (3 - 9 - 18 MIU) 5 days per week, subcutaneously for 4 weeks

Timeline

• Start date: 2011-04-01
• Primary completion: 2013-03-01
• Completion: 2013-03-01
• First posted: 2011-04-25
• Last updated: 2014-11-13

Locations

1 site across 1 country: Germany