Efficacy Study of IL-21 to Treat Metastatic Melanoma

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. Identifier: NCT00336986
Recruitment Status : Completed
First Posted : June 15, 2006
Last Update Posted : November 11, 2016
Information provided by (Responsible Party):
Novo Nordisk A/S

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.

Condition or disease Intervention/treatment Phase
Cancer Malignant Melanoma Drug: recombinant interleukin-21 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : September 2004
Actual Primary Completion Date : October 2007
Actual Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma
U.S. FDA Resources

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

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

Information from the National Library of Medicine

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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Additional Information:
Publications of Results:
Responsible Party: Novo Nordisk A/S Identifier: NCT00336986     History of Changes
Other Study ID Numbers: NN028-1614
First Posted: June 15, 2006    Key Record Dates
Last Update Posted: November 11, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas