Can a modified virus shrink Hard-to-Treat melanoma tumors?
NCT ID NCT00429312
First seen Jul 27, 2026 · Last updated Jul 28, 2026 · Updated 1 time
Summary
This trial is testing whether a modified virus called JX-594 (Pexa-Vec) can safely and effectively shrink tumors in people with advanced melanoma that cannot be surgically removed. The virus is injected directly into the tumor and is designed to infect and kill cancer cells while also stimulating the immune system. The study includes about 10 adults with stage 3 or 4 melanoma who have at least one injectable tumor.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- a modified vaccinia virus (JX-594, also called Pexa-Vec) that is injected directly into tumors
- What this could lead to
- If it works, this could offer a new treatment option for people with advanced melanoma that cannot be removed by surgery.
- What could go wrong
- This is an early-phase trial with only 10 participants, so the results may not apply to everyone. The virus may cause side effects or fail to shrink tumors.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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10 people
The number who actually took part.
- Start date
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Feb 2007
- Finished
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Dec 2009
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Histologically-confirmed, Stage 3 or Stage 4 malignant melanoma * At least one tumor mass measurable by CT/MRI and/or physical examination that can be injected by direct visualization or by ultrasound-guidance * Anticipated survival of at least 16 weeks * Cancer is not surgically resectable for cure * KPS score of ≥ 70 (refer to APPENDIX E: KARNOFSKY PERFORMANCE STATUS (KPS)) * Age ≥18 years * Men and women of reproductive potential must be willing to follow accepted birth control methods during treatment and for 3 months after the last treatment with JX-594 * The ability to understand and willingness to sign an Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved written informed consent form * Able to comply with study procedures and follow-up examinations * Adequate liver function: Total bilirubin ≤ 2.0 x ULN; AST, ALT ≤ 2.0 x ULN * Adequate bone marrow function: WBC \> 3,500 cells/mm3 and \< 50,000 cells/mm3; ANC \> 1,500 cells/mm3; Hemoglobin \> 10 g/dL; Platelet count \> 125,000 plts/mm3 * Acceptable coagulation status: INR \< (ULN + 10%) * Acceptable kidney function: Serum creatinine \< 2.0 mg/dL Exclusion Criteria: * Target tumor(s) adherent to and/or invading a major vascular structure (e.g. carotid artery) * Pregnant or nursing an infant * Known infection with HIV * Systemic corticosteroid or other immunosuppressive medication use within 4 weeks of first treatment with JX-594 * Clinically significant active infection or uncontrolled medical condition (e.g. pulmonary, neurological, cardiovascular, gastrointestinal, genitourinary) considered high risk for investigational new drug treatment Significant immunodeficiency due to underlying illness and/or medication (e.g. systemic corticosteroids) * History of eczema that at some stage has required systemic therapy * Clinically significant and/or rapidly accumulating ascites, peri-cardial and/or pleural effusions (e.g. requiring drainage for symptom control) * Severe or unstable cardiac disease which includes, but is not limited to, any of the following within 6 months prior to screening: myocardial infarct, unstable angina, congestive heart failure, myocarditis, arrhythmias diagnosed and requiring medication, or any clinically-significant change in cardiac status * Treatment of the target tumor(s) with radiotherapy, chemotherapy, surgery, or an investigational drug within 4 weeks of screening (6 weeks in case of mitomycin C or nitrosoureas) * Experienced a severe reaction or side-effect as a result of a previous smallpox vaccination * Inability or unwillingness to give informed consent or comply with the procedures required in this protocol * Patients with household contacts who are pregnant or nursing an infant, children \< 5 years old, have history of eczema that at some stage has required systemic therapy, or have a significant immunodeficiency due to underlying illness (e.g. HIV) and/or medication (e.g. systemic corticosteroids) will be excluded unless alternate living arrangements can be made during the patient's active dosing period and for three weeks following the last dose of study medication.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Billings Clinic
Billings, Montana, 59101, United States
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Cancer Centers of the Carolinas
Greenville, South Carolina, 29605, United States
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University of California, Los Angeles
Los Angeles, California, 90024, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- New antibody GNR-051 tested for safety in Hard-to-Treat cancers
- Blood test could spot Melanoma's BRAF mutation
- Can a CXCR1/2 blocker boost radiation against cancer that spreads to the brain lining?
- Can a new antibody help the immune system fight Hard-to-Treat tumors?
- Can tumor DNA and immune cells reveal why some cancers resist immunotherapy?
- Can a Two-Drug immune combo shrink melanoma tumors?