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Completed

NCT Number: NCT00336986

Efficacy Study of IL-21 to Treat Metastatic 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.

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Key information

Conditions

Cancer Malignant Melanoma Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Novo Nordisk Investigational Site, Box Hill, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

recombinant interleukin-21

Drug

Primary outcomes

  1. Tumor size assessed according to international criteria

    Time frame: After 8 weeks

Secondary outcomes

  1. Serum levels of antibodies against recombinant human IL-21.

  2. Markers of immunomodulation in blood.

  3. Safety evaluation.

  4. Time to progression.

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study 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

Important dates

Study start
2004
Primary completion
2007
Study completion
2007
First posted
Jun 15, 2006
Registry last updated
Aug 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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