Status:
COMPLETED
Viral Therapy in Treating Patients With Metastatic Melanoma
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Recurrent Melanoma
Stage IV Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 c...
Detailed Description
PRIMARY OBJECTIVES: I. 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 pati...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT00651157
Start Date
April 1 2008
End Date
October 1 2012
Last Update
April 22 2014
Active Locations (1)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55905