NCT00601861

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for phase_2 cancer

Timeline
Completed

Started Feb 2008

Shorter than P25 for phase_2 cancer

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 3, 2008

Completed
25 days until next milestone

First Posted

Study publicly available on registry

January 28, 2008

Completed
16 days until next milestone

Study Start

First participant enrolled

February 13, 2008

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 25, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 25, 2008

Completed
Last Updated

March 1, 2017

Status Verified

February 1, 2017

Enrollment Period

4 months

First QC Date

January 3, 2008

Last Update Submit

February 28, 2017

Conditions

CancerMalignant Melanoma

Outcome Measures

Primary Outcomes (1)

  • Complete pathological response rate in the lymph nodes

    After 4 weeks of treatment

Secondary Outcomes (3)

  • 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)

Study Arms (1)

A

EXPERIMENTAL
Drug: recombinant interleukin-21

Interventions

recombinant interleukin-21DRUG

Fixed and equal dose for s.c. injection, 3 times weekly

Also known as: rIL-21, NN028
A

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Stage III melanoma
  • ECOG performance status 0-1

You may not qualify if:

  • Signs of stage IV melanoma
  • Safety variables

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novo Nordisk Investigational Site

Berlin, 10119, Germany

Location

Related Links

MeSH Terms

Conditions

NeoplasmsMelanoma

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Global Clinical Registry (GCR, 1452)

    Novo Nordisk A/S

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 3, 2008

First Posted

January 28, 2008

Study Start

February 13, 2008

Primary Completion

June 25, 2008

Study Completion

June 25, 2008

Last Updated

March 1, 2017

Record last verified: 2017-02

Locations

DE(1)