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:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00601861
First received: January 3, 2008
Last updated: October 24, 2013
Last verified: October 2013
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety [ Time Frame: For the duration of the trial ] [ Designated as safety issue: Yes ]
  • Immunomodulatory effects [ Time Frame: For the duration of the trial ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]

Enrollment: 1
Study Start Date: February 2008
Study Completion Date: June 2008
Primary Completion Date: June 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00601861

Locations
Germany
Berlin, Germany, 10119
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Paul Kristjansen, MD, PhD, DMSc Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00601861     History of Changes
Other Study ID Numbers: NN028-1801, 2006-005350-79
Study First Received: January 3, 2008
Last Updated: October 24, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

ClinicalTrials.gov processed this record on April 16, 2014