Viral Therapy in Treating Patients With Metastatic Melanoma

Completed · Phase 2

Conditions studied: Recurrent Melanoma, Stage IV Melanoma

In brief

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.

Key facts

Study ID

NCT00651157

Run by

National Cancer Institute (NCI)

People needed

23

Starts

2008-04-01

Expected to finish

2012-10-01

Last updated by the study team

2014-04-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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:

Where it is running

• Mayo Clinic — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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