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NCT00336986 Clinical Trial

Efficacy Study of IL-21 to Treat Metastatic Melanoma

Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00336986
Other study ID # NN028-1614
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date September 2004
Est. completion date October 2007

Study information
Verified date August 2023
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 54
Est. completion date October 2007
Est. primary completion date October 2007
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• recombinant interleukin-21

Locations
Country Name City State
Australia Novo Nordisk Investigational Site Box Hill
Australia Novo Nordisk Investigational Site East Melbourne
Australia Novo Nordisk Investigational Site Heidelberg
Australia Novo Nordisk Investigational Site Malvern
Australia Novo Nordisk Investigational Site Nedlands
Australia Novo Nordisk Investigational Site Parkville
Australia Novo Nordisk Investigational Site Westmead

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

Country where clinical trial is conducted

Australia, 

References & Publications (1)

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Tumor size assessed according to international criteria After 8 weeks
Secondary Serum levels of antibodies against recombinant human IL-21.
Secondary Markers of immunomodulation in blood.
Secondary Safety evaluation.
Secondary Time to progression.
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