Iris Melanoma Clinical Trial
Official title:
Adjuvant Therapy for Patients With Primary Uveal Melanoma With Genetic Imbalance
RATIONALE: Drugs used in chemotherapy, such as dacarbazine, work in different ways to stop
the growth of tumor cells, either by killing the cells or by stopping them from dividing.
Recombinant interferon alfa-2b may interfere with the growth of tumor cells. Giving
interferon alfa-2b together with dacarbazine may be an effective treatment for primary uveal
melanoma.
PURPOSE: This phase II trial is studying how well giving dacarbazine together with
recombinant interferon alfa-2b works in treating patients with primary uveal melanoma with
genetic imbalance.
PRIMARY OBJECTIVES:
I. Assess disease-free survival (DFS) with sequential dacarbazine and interferon-alfa-2b as
an adjuvant to primary therapy for patients with uveal melanoma with genetic imbalance.
SECONDARY OBJECTIVES:
I. Evaluate side effects and assess safety in the patient population.
II. Examine the relationship between the levels of plasma biomarkers of immune function and
tumor invasion and the clinical outcome.
OUTLINE: Patients receive dacarbazine IV on days 1 and 29. Beginning 4 weeks after the second
dose of dacarbazine, patients receive recombinant interferon alfa-2b subcutaneously 3 times a
week for 24 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 6 months.
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