Stage IV Melanoma Clinical Trial
Official title:
Phase II Trial Of Interferon-B In Patients With Metastatic Cutaneous Melanoma And Metastatic Ocular Melanoma
RATIONALE: Interferon beta may interfere with the growth of tumor cells.
PURPOSE: This phase II trial is studying how well interferon beta works in treating patients
with metastatic cutaneous (skin) melanoma or ocular (eye) melanoma.
OBJECTIVES:
- Determine the objective clinical response rate in patients with metastatic cutaneous or
ocular melanoma treated with interferon beta.
- Determine the frequency and degree of apoptosis induction in patients treated with this
drug.
- Determine the safety and tolerability of this drug in these patients.
OUTLINE: This is an open-label study. Patients are stratified according to type of melanoma
(ocular vs cutaneous).
Patients receive interferon beta subcutaneously once daily in the absence of disease
progression or unacceptable toxicity.
Patients are followed within 3 days after completion of study treatment and then for
survival.
PROJECTED ACCRUAL: A total of 28-56 patients (14-28 per stratum) will be accrued for this
study.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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