Clinical trial · Interventional
Viral Therapy in Treating Patients With Metastatic Melanoma
A Phase II Trial of Intravenous Administration of Reovirus Serotype 3 - Dearing Strain (Reolysin®) in Patients With Metastatic Melanoma
NCT00651157CI-TRIAL-00014317completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| wild-type reovirus | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (viral therapy)
- description
- Patients receive wild-type reovirus (Reolysin®) 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. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Biological: wild-type reovirus
Primary outcomes (1)
- measure
- Tumor Response
- timeFrame
- Every 4 weeks after 4 courses of treatment, assessed up to 5 years
- description
- A tumor response is defined to be a Complete Response (CR) or Partial Response (PR) as defined by the Response Evaluation Criteria in Solid Tumors (RECIST) noted as the objective status on 2 consecutive evaluations at least 4 weeks apart. Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the largest dimension (LD) of target lesions taking as reference the baseline sum LD.
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.