Study of T-VEC in Locally Advanced Cutaneous Angiosarcoma (NCT03921073) | Clinical Trial Compass
TerminatedPhase 2
Study of T-VEC in Locally Advanced Cutaneous Angiosarcoma
Stopped: Sponsor Terminated Funding
United States5 participantsStarted 2019-08-20
Plain-language summary
This is a single-arm study evaluating the efficacy of injecting Talimogene Laherparepvec T-VEC into Cutaneous Angiosarcoma tumors.
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:
* Participants must have histologically confirmed CA without visceral or CNS metastases, with resection deemed of no benefit by technical or oncologic principles, and have progressed on at least one line of systemic therapy
* Participants must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded by digital photography) as \>6 mm with calipers or a ruler.
* Eastern Cooperative Oncology Group performance status 0-1 (Karnofsky \>70%).
* Participants must have normal organ and marrow function as defined below:
* Hematological
* Absolute neutrophil count \> 1500/mm3 (1.5x109/L)
* Platelet count \>75,000/mm3 (7.5x109/L)
* Hemoglobin \>8 g/dL (without need for hematopoietic growth factor or transfusion support)
* Renal
* Serum creatinine ≤1.5 x upper limit of normal (ULN), OR 24-hour creatinine clearance \>60 mL/min for subject with creatinine levels \> 1.5 x ULN. (Note: Creatinine clearance need not be determined if the baseline serum creatinine is ≤1.5 x ULN. . Creatinine clearance should be determined per institutional standard).
* Hepatic
* Serum bilirubin ≤1.5 x ULN OR direct bilirubin ≤ ULN for a subject with total bilirubin level \> 1.5 x ULN
* Aspartate aminotransferase (AST) ≤2.5 x ULN OR \<5 x ULN, if liver metastases present and injection does not involve a visceral lesion
* Alanine aminotransferase (ALT) ≤2.5 x ULN OR \<5 x ULN, if liver metastases present a…
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
Overall Response Rate
Timeframe: at 24 Weeks
Trial details
NCT IDNCT03921073
SponsorH. Lee Moffitt Cancer Center and Research Institute