Back to resultsEfficacy Study of IL-21 to Treat Metastatic Melanoma
Primary Purpose
Cancer, Malignant Melanoma
Status
Completed
Phase
Phase 2
Locations
Australia
Study Type
Interventional
Intervention
recombinant interleukin-21
Sponsored by
About this trial
This is an interventional treatment trial for Cancer
Eligibility Criteria
Inclusion Criteria: Histologically confirmed surgically incurable metastatic melanoma Patients must have measurable disease ECOG performance status of 0 or 1 Expected life expectancy at least 4 months Exclusion Criteria: History of and signs/symptoms of uncontrolled brain metastases or edema. Previous treatment with chemotherapy or any biological anti-cancer drug (prior adjuvant therapy with interferon-alpha is permitted as long as treatment was completed at least six months prior to study entry.) Radiotherapy: Radiation therapy within 4 weeks prior to entering the study. Receipt of any investigational drug for treatment of metastatic melanoma prior to this trial.
Sites / Locations
- Novo Nordisk Investigational Site
- Novo Nordisk Investigational Site
- Novo Nordisk Investigational Site
- Novo Nordisk Investigational Site
- Novo Nordisk Investigational Site
- Novo Nordisk Investigational Site
- Novo Nordisk Investigational Site
Outcomes
Primary Outcome Measures
Tumor size assessed according to international criteria
Secondary Outcome Measures
Serum levels of antibodies against recombinant human IL-21.
Markers of immunomodulation in blood.
Safety evaluation.
Time to progression.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00336986
Brief Title
Efficacy Study of IL-21 to Treat Metastatic Melanoma
Official Title
An Open-label, Dose Escalation Safety and Tolerability Study of Recombinant Human Interleukin-21 (Phase 1) Followed by an Open-label Treatment Study (Phase 2a) in Patients With Stage IV Malignant Melanoma
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
September 2004 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
October 2007 (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
This trial is conducted in Oceania. A phase 2a study to assess the effect on tumor size. At least 14 to a maximum of 40 patients, who have not previously received treatment for their stage IV disease, will be treated for 6 weeks. IL-21 will be administered intravenously.
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
54 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
recombinant interleukin-21
Primary Outcome Measure Information:
Title
Tumor size assessed according to international criteria
Time Frame
After 8 weeks
Secondary Outcome Measure Information:
Title
Serum levels of antibodies against recombinant human IL-21.
Title
Markers of immunomodulation in blood.
Title
Safety evaluation.
Title
Time to progression.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologically confirmed surgically incurable metastatic melanoma
Patients must have measurable disease
ECOG performance status of 0 or 1
Expected life expectancy at least 4 months
Exclusion Criteria:
History of and signs/symptoms of uncontrolled brain metastases or edema.
Previous treatment with chemotherapy or any biological anti-cancer drug (prior adjuvant therapy with interferon-alpha is permitted as long as treatment was completed at least six months prior to study entry.)
Radiotherapy: Radiation therapy within 4 weeks prior to entering the study.
Receipt of any investigational drug for treatment of metastatic melanoma prior to this trial.
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
Box Hill
ZIP/Postal Code
3128
Country
Australia
Facility Name
Novo Nordisk Investigational Site
City
East Melbourne
ZIP/Postal Code
3002
Country
Australia
Facility Name
Novo Nordisk Investigational Site
City
Heidelberg
ZIP/Postal Code
3084
Country
Australia
Facility Name
Novo Nordisk Investigational Site
City
Malvern
ZIP/Postal Code
3144
Country
Australia
Facility Name
Novo Nordisk Investigational Site
City
Nedlands
ZIP/Postal Code
6009
Country
Australia
Facility Name
Novo Nordisk Investigational Site
City
Parkville
ZIP/Postal Code
3050
Country
Australia
Facility Name
Novo Nordisk Investigational Site
City
Westmead
ZIP/Postal Code
2145
Country
Australia
12. IPD Sharing Statement
Citations:
PubMed Identifier
25505948
Citation
Coquet JM, Skak K, Davis ID, Smyth MJ, Godfrey DI. IL-21 Modulates Activation of NKT Cells in Patients with Stage IV Malignant Melanoma. Clin Transl Immunology. 2013 Oct 18;2(10):e6. doi: 10.1038/cti.2013.7. eCollection 2013 Oct.
Results Reference
result
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk
Learn more about this trial
Efficacy Study of IL-21 to Treat Metastatic Melanoma
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