ClinicalTrials.gov Updated: Now Recruiting Viral Therapy in Treating Patients With Metastatic Melanoma

Viral Therapy in Treating Patients With Metastatic Melanoma

RATIONALE: Viral therapy may be able to kill tumor cells without damaging normal cells.
PURPOSE: This phase II trial is studying the side effects and how well viral therapy works in treating patients with metastatic melanoma.

OBJECTIVES:

Primary

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  To assess the antitumor effect of wild-type reovirus (Reolysin®), in terms of tumor response rate and clinical benefit rate (i.e., partial response and complete response), in patients with metastatic melanoma.
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  To assess the toxicity profile of Reolysin® in these patients.
  

Secondary

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  To assess the progression-free survival and overall survival of these patients.
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  To assess viral replication in metastatic melanoma deposits after intravenous administration of Reolysin®.
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  To assess the impact of pre-existing anti-reoviral immunity (as represented by p38 expression in pretreatment tumor specimens) on the efficacy and toxicity of Reolysin®.
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  To measure the effect of Reolysin® on the immune system, in terms of dendritic cell activation, T-cell activation, presence of Treg cells in tumor specimens, and the frequency of T cells, B cells, NK cells, and peptide specific cytotoxic T lymphocytes reactive against melanoma differentiation antigen peptides (gp100, MART-1, and tyrosinase).
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  To assess the induction of melanoma specific immune response, in terms of the presence of melanoma differentiation antigens (gp100, MART-1, and tyrosinase) in tumor specimens.

OUTLINE:

This is a multicenter study.
Patients receive wild-type reovirus (Reolysin®) IV over 60 minutes on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

Tumor tissue samples are collected at baseline and at 1 week after initiation of treatment for correlative laboratory studies. Tissue samples are analyzed for p38/MAPK activation status by IHC; reoviral replication in metastatic deposits by electron microscopy; and immunologic parameters by IHC. Blood samples are collected at baseline, at 4 weeks after initiation of treatment, and then every 2 months thereafter. Blood samples are analyzed for immunologic parameters by tetramer and ELISPOT technology and for neutralizing antibodies against reovirus.

After completion of study treatment, patients are followed every 6 months for 2 years and then annually for up to 5 years