Viral Therapy in Treating Patients With Metastatic Melanoma
Condition: Recurrent Melanoma; Stage IV Melanoma
MeSH terms: Melanoma
Intervention: wild-type reovirus
Intervention description: Given IV: Administered at a dose of 3 x 10^10 TCID50/day in 250 mL 0.9% sodium chloride infused intravenously over 60 minutes daily on days 1-5 of each 28-day cycle.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 23.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

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

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically confirmed malignant melanoma

               -  All melanomas, regardless of origin, are allowed

               -  Metastatic disease

          -  Measurable disease, defined as ≥ 1 lesion that can be accurately measured in ≥ 1
             dimension (longest diameter to be recorded) as ≥ 20mm by conventional techniques or as
             ≥ 10 mm by spiral CT scan

          -  Must have ≥ 1 metastatic lesion that can be safely biopsied

          -  Must have received ≥ 1 prior treatment for metastatic disease

          -  Not a candidate for curative surgery for metastatic disease

          -  No known brain metastases

          -  Eastern Cooperative Oncology Group performance status 0-2

          -  Life expectancy > 12 weeks

          -  Total White Blood Cell (WBC) ≥ 3,000/mcL

          -  Absolute neutrophil count ≥ 1,500/mcL

          -  Platelet count ≥ 100,000/mcL

          -  Hemoglobin ≥ 9 g/dL

          -  Total bilirubin ≤ 1.5 times upper limit of normal (ULN)

          -  Aspartate Aminotransferase (AST) ≤ 2.5 times ULN

          -  Creatinine ≤ 1.5 times ULN

          -  Troponin-T normal

          -  Left ventricular ejection fraction (LVEF) ≥ 50% by ECHO or MUGA

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  Agrees to provide blood and tissue samples for the mandatory translational research
             component of the study

          -  Must be able to avoid direct contact with pregnant or nursing women, infants, and
             immuno compromised individuals during study and for ≥ 3 weeks following the last dose
             of study agent

          -  No concurrent uncontrolled illness including, but not limited to, any of the
             following:

               -  Ongoing or active infection

               -  Symptomatic congestive heart failure

               -  Unstable angina pectoris, cardiac arrhythmia, or myocardial infarction within the
                  past year

               -  Psychiatric illness/social situation that would preclude study compliance

          -  No known HIV positivity

               -  Patients with a clinical history suggestive of an immuno compromised status are
                  required to undergo HIV testing

          -  More than 4 weeks since prior chemotherapy (6 weeks for mitomycin C or nitrosoureas)
             and recovered

          -  More than 2 weeks since prior radiotherapy, immunotherapy, or treatment with small
             molecule cell cycle inhibitors

          -  No other concurrent investigational agents

          -  No other concurrent anticancer therapy