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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 01, 2014