Back to resultsEffect of rIL-21 on Metastases in Lymph Nodes in Melanoma Skin Cancer
Primary Purpose
Cancer, Malignant Melanoma
Status
Terminated
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
recombinant interleukin-21
Sponsored by
About this trial
This is an interventional treatment trial for Cancer
Eligibility Criteria
Inclusion Criteria:
- Stage III melanoma
- ECOG performance status 0-1
Exclusion Criteria:
- Signs of stage IV melanoma
- Safety variables
Sites / Locations
- Novo Nordisk Investigational Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
A
Arm Description
Outcomes
Primary Outcome Measures
Complete pathological response rate in the lymph nodes
Secondary Outcome Measures
Safety
Immunomodulatory effects
Relapse free survival
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00601861
Brief Title
Effect of rIL-21 on Metastases in Lymph Nodes in Melanoma Skin Cancer
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Terminated
Why Stopped
See termination reason in detailed description
Study Start Date
February 13, 2008 (Actual)
Primary Completion Date
June 25, 2008 (Actual)
Study Completion Date
June 25, 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, Malignant Melanoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
recombinant interleukin-21
Other Intervention Name(s)
rIL-21, NN028
Intervention Description
Fixed and equal dose for s.c. injection, 3 times weekly
Primary Outcome Measure Information:
Title
Complete pathological response rate in the lymph nodes
Time Frame
After 4 weeks of treatment
Secondary Outcome Measure Information:
Title
Safety
Time Frame
For the duration of the trial
Title
Immunomodulatory effects
Time Frame
For the duration of the trial
Title
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Stage III melanoma
ECOG performance status 0-1
Exclusion Criteria:
Signs of stage IV melanoma
Safety variables
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Registry (GCR, 1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Berlin
ZIP/Postal Code
10119
Country
Germany
12. IPD Sharing Statement
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk
Learn more about this trial
Effect of rIL-21 on Metastases in Lymph Nodes in Melanoma Skin Cancer
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