Viral Therapy in Treating Patient With Refractory Liver Cancer or Advanced Solid Tumors (NCT01628640) | Clinical Trial Compass
CompletedPhase 1
Viral Therapy in Treating Patient With Refractory Liver Cancer or Advanced Solid Tumors
United States17 participantsStarted 2012-08-03
Plain-language summary
This phase I trial studies the best dose and side effects of recombinant vesicular stomatitis virus expressing interferon beta in treating patients with liver cancer or solid tumors with lesions that have spread to other parts of the body and do not respond to treatment. The study virus has a gene inserted into it which will allow production of interferon beta, which is a substance that will restrict the spread of the virus to tumor cells and not healthy cells. It will also have some independent anti-cancer activity. Although the primary goal of this study is to evaluate the safety of delivery of this viral agent to people, patients may benefit clinically by having shrinkage or stabilization of their tumor or reduction in their cancer related symptoms (e.g., pain). Funding Source - FDA OOPD.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* ARM A: Histologically or cytologically confirmed hepatocellular carcinoma that is refractory (by Response Evaluation Criteria in Solid Tumors \[RECIST\] or modified \[m\]RECIST criteria or with unequivocal clinical progression of disease) to or intolerant (defined as inability to administer further sorafenib due to drug related toxicities) of sorafenib based therapy or advanced solid tumor with liver predominant disease burden that has progressed on or is intolerant to standard
* ARM A: Absolute neutrophil count (ANC) \>= 1000/mm\^3
* ARM A: Platelet count \>= 80,000/mm\^3
* ARM A: Hemoglobin \>= 10 g/dl
* ARM A: Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =\< 5 x ULN
* ARM A: Creatinine =\< 1.5 x ULN
* ARM A: Total bilirubin =\< 1.5 x ULN
* ARM A: International normalized ratio (INR) =\< 1.5 x ULN
* ARM A: Activated partial thromboplastin time (aPTT) =\< 1.5 x ULN
* ARM A: Ability to provide informed written consent
* ARM A: Willingness to return to Mayo Clinic in Arizona for follow-up
* ARM A: Life expectancy \>= 12 weeks
* ARM A: Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
* ARM A: Willingness to provide all biological specimens as required by the protocol
* ARM A: Negative serum pregnancy test =\< 7 days prior to registration for women of childbearing potential only
* ARM A: Child Pugh Score A or B7 (patients with ascites must have paracentesis performed within scope of standard of care, to be able to…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Best tumor response, defined as the best objective status recorded among patients with measurable disease at baseline using Response Evaluation Criteria in Solid Tumors version 1.1
Timeframe: From the start of the treatment until disease progression, assessed up to 3 years
2
Incidence of adverse events, graded according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0
Timeframe: Up to 3 years
3
Maximum tolerated dose, defined as the highest dose at which no more than 1/6 patients experiences dose limiting toxicities, graded according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0
Timeframe: 4 weeks
4
Overall survival
Timeframe: From registration to death due to any cause, assessed up to 3 years