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 range18 Years
SexALL
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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…
What they're measuring
1
Overall Response Rate
Timeframe: at 24 Weeks
Trial details
NCT IDNCT03921073
SponsorH. Lee Moffitt Cancer Center and Research Institute