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

This study has been terminated.
(See termination reason in detailed description)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00601861
First Posted: January 28, 2008
Last Update Posted: March 1, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novo Nordisk A/S
  Purpose
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

Condition Intervention Phase
Cancer Malignant Melanoma Drug: recombinant interleukin-21 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Complete pathological response rate in the lymph nodes [ Time Frame: After 4 weeks of treatment ]

Secondary Outcome Measures:
  • Safety [ Time Frame: For the duration of the trial ]
  • Immunomodulatory effects [ Time Frame: 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) ]

Enrollment: 1
Actual Study Start Date: February 13, 2008
Study Completion Date: June 25, 2008
Primary Completion Date: June 25, 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: recombinant interleukin-21
Fixed and equal dose for s.c. injection, 3 times weekly
Other Name: rIL-21, NN028

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Stage III melanoma
  • ECOG performance status 0-1

Exclusion Criteria:

  • Signs of stage IV melanoma
  • Safety variables
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00601861


Locations
Germany
Novo Nordisk Investigational Site
Berlin, Germany, 10119
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00601861     History of Changes
Other Study ID Numbers: NN028-1801
2006-005350-79 ( EudraCT Number )
First Submitted: January 3, 2008
First Posted: January 28, 2008
Last Update Posted: March 1, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas