Efficacy Study of IL-21 to Treat Metastatic Melanoma
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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.
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
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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.