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NCT00601861 Clinical Trial

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

Cancer Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00601861
Other study ID # NN028-1801
Secondary ID 2006-005350-79
Status Terminated
Phase Phase 2
First received January 3, 2008
Last updated February 28, 2017
Start date February 13, 2008
Est. completion date June 25, 2008

Study information
Verified date February 2017
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

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.

Recruitment information / eligibility
Status Terminated
Enrollment 1
Est. completion date June 25, 2008
Est. primary completion date June 25, 2008
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Stage III melanoma

- ECOG performance status 0-1

Exclusion Criteria:

- Signs of stage IV melanoma

- Safety variables

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• recombinant interleukin-21
Fixed and equal dose for s.c. injection, 3 times weekly

Locations
Country Name City State
Germany Novo Nordisk Investigational Site Berlin

Sponsors (1)
Lead Sponsor Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Complete pathological response rate in the lymph nodes After 4 weeks of treatment
Secondary Safety For the duration of the trial
Secondary Immunomodulatory effects For the duration of the trial
Secondary 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)
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