Efficacy Study of IL-21 to Treat Metastatic Melanoma

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00336986
First received: June 14, 2006
Last updated: October 24, 2013
Last verified: October 2013

June 14, 2006
October 24, 2013
September 2004
October 2007   (final data collection date for primary outcome measure)
Tumor size assessed according to international criteria [ Time Frame: After 8 weeks ] [ Designated as safety issue: No ]
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. [ Designated as safety issue: No ]
  • Markers of immunomodulation in blood. [ Designated as safety issue: No ]
  • Safety evaluation. [ Designated as safety issue: No ]
  • Time to progression. [ Designated as safety issue: No ]
  • Serum levels of antibodies against recombinant human IL-21.
  • Markers of immunomodulation in blood.
  • Safety evaluation.
  • 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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Cancer
  • Malignant Melanoma
Drug: recombinant interleukin-21
Not Provided
Not Provided

*   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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Australia
 
NCT00336986
NN028-1614
No
Not Provided
Novo Nordisk A/S
Not Provided
Study Director: Birte K. Skrumsager, MSc Novo Nordisk A/S
Novo Nordisk A/S
October 2013

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