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Efficacy Study of IL-21 to Treat Metastatic Melanoma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00336986
First Posted: June 15, 2006
Last Update Posted: November 11, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novo Nordisk A/S
June 14, 2006
June 15, 2006
November 11, 2016
September 2004
October 2007   (Final data collection date for primary outcome measure)
Tumor size assessed according to international criteria [ Time Frame: After 8 weeks ]
Tumor size assessed according to international criteria after 8 weeks
Complete list of historical versions of study NCT00336986 on ClinicalTrials.gov Archive Site
  • Serum levels of antibodies against recombinant human IL-21.
  • Markers of immunomodulation in blood.
  • Safety evaluation.
  • Time to progression.
  • Safety evaluation.
  • Markers of immunomodulation in blood.
  • Serum levels of antibodies against recombinant human IL-21.
  • Time to progression.
Not Provided
Not Provided
 
Efficacy Study of IL-21 to Treat Metastatic Melanoma
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
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.
Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Cancer
  • Malignant Melanoma
Drug: recombinant interleukin-21
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
54
October 2007
October 2007   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Australia
 
 
NCT00336986
NN028-1614
No
Not Provided
Not Provided
Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Global Clinical Registry (GCR; 1452) Novo Nordisk A/S
Novo Nordisk A/S
November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP