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Efficacy Study of IL-21 to Treat Metastatic Melanoma

This study has been completed.
Information provided by (Responsible Party):
Novo Nordisk A/S Identifier:
First received: June 14, 2006
Last updated: November 10, 2016
Last verified: November 2016
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.

Condition Intervention Phase
Malignant Melanoma
Drug: recombinant interleukin-21
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Tumor size assessed according to international criteria [ Time Frame: After 8 weeks ]

Secondary Outcome Measures:
  • Serum levels of antibodies against recombinant human IL-21.
  • Markers of immunomodulation in blood.
  • Safety evaluation.
  • Time to progression.

Enrollment: 54
Study Start Date: September 2004
Study Completion Date: October 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00336986

Novo Nordisk Investigational Site
Box Hill, Australia, 3128
Novo Nordisk Investigational Site
East Melbourne, Australia, 3002
Novo Nordisk Investigational Site
Heidelberg, Australia, 3084
Novo Nordisk Investigational Site
Malvern, Australia, 3144
Novo Nordisk Investigational Site
Nedlands, Australia, 6009
Novo Nordisk Investigational Site
Parkville, Australia, 3050
Novo Nordisk Investigational Site
Westmead, Australia, 2145
Sponsors and Collaborators
Novo Nordisk A/S
Study Director: Global Clinical Registry (GCR; 1452) Novo Nordisk A/S
  More Information

Additional Information:
Responsible Party: Novo Nordisk A/S Identifier: NCT00336986     History of Changes
Other Study ID Numbers: NN028-1614
Study First Received: June 14, 2006
Last Updated: November 10, 2016

Additional relevant MeSH terms:
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas processed this record on April 24, 2017