Effect of rIL-21 on Metastases in Lymph Nodes in Melanoma Skin Cancer

Phase 2

Terminated

• Conditions: Cancer; Malignant Melanoma
• Interventions: Drug: recombinant interleukin-21

• Registration Number: NCT00601861
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

The trial is conducted in Europe. This trial aims for a comparison of the pathology in lymph nodes before and after the effect of recombinant interleukin-21 in patients with stage III melanoma

Detailed Description

The decision to discontinue the NN028-1801 trial is not due to any safety concerns. The trial was terminated as a result of a strategic decision by the sponsoring company.

Study Timeline

• Study First Submitted: 2008-01-03
• Study First Submitted QC: 2008-01-15
• Study First Posted: 2008-01-28
• Study Start: 2008-02-13
• Primary Completion: 2008-06-25
• Study Completion: 2008-06-25
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-28
• Last Update Posted: 2017-03-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

• Stage III melanoma
• ECOG performance status 0-1

Exclusion Criteria

• Signs of stage IV melanoma
• Safety variables

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A	recombinant interleukin-21	-

Primary Outcome Measures

Name	Time	Method
Complete pathological response rate in the lymph nodes	After 4 weeks of treatment

Secondary Outcome Measures

Name	Time	Method
Safety	For the duration of the trial
Immunomodulatory effects	For the duration of the trial
Relapse free survival	For up to 4 years after the final visit or until progression of the disease in order to assess the relapse free survival (RFS)

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇩🇪 Berlin, Germany