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

NCT ID: NCT00601861

Last Updated: 2017-03-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-13

Study Completion Date

2008-06-25

Brief Summary

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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

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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.

Conditions

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Cancer Malignant Melanoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

Group Type EXPERIMENTAL

recombinant interleukin-21

Intervention Type DRUG

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

Interventions

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recombinant interleukin-21

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

Intervention Type DRUG

Other Intervention Names

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rIL-21, NN028

Eligibility Criteria

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Inclusion Criteria

* Stage III melanoma
* ECOG performance status 0-1

Exclusion Criteria

* Signs of stage IV melanoma
* Safety variables
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Global Clinical Registry (GCR, 1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

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Novo Nordisk Investigational Site

Berlin, , Germany

Site Status

Countries

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Germany

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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2006-005350-79

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

NN028-1801

Identifier Type: -

Identifier Source: org_study_id

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