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
  Purpose

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
Cancer
Malignant Melanoma
Drug: recombinant interleukin-21
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

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)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00336986

Locations
Australia
East Melbourne, Australia, 3002
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Birte K. Skrumsager, MSc Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00336986     History of Changes
Other Study ID Numbers: NN028-1614
Study First Received: June 14, 2006
Last Updated: October 24, 2013
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

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

ClinicalTrials.gov processed this record on April 17, 2014