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

February 28, 2017 updated by: Novo Nordisk A/S

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 Subjects With Stage III Malignant Melanoma

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

1

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 10119
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Stage III melanoma
  • ECOG performance status 0-1

Exclusion Criteria:

  • Signs of stage IV melanoma
  • Safety variables

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
Drug: recombinant interleukin-21
Fixed and equal dose for s.c. injection, 3 times weekly
Other Names:
  • rIL-21, NN028

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Complete pathological response rate in the lymph nodes
Time Frame: After 4 weeks of treatment
After 4 weeks of treatment

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 13, 2008

Primary Completion (Actual)

June 25, 2008

Study Completion (Actual)

June 25, 2008

Study Registration Dates

First Submitted

January 3, 2008

First Submitted That Met QC Criteria

January 15, 2008

First Posted (Estimate)

January 28, 2008

Study Record Updates

Last Update Posted (Actual)

March 1, 2017

Last Update Submitted That Met QC Criteria

February 28, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN028-1801
  • 2006-005350-79 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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