Study of T-VEC in Locally Advanced Cutaneous Angiosarcoma
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|ClinicalTrials.gov Identifier: NCT03921073|
Recruitment Status : Recruiting
First Posted : April 19, 2019
Last Update Posted : April 22, 2019
|Condition or disease||Intervention/treatment||Phase|
|Angiosarcoma of Skin||Drug: T-VEC||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||13 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Talimogene Laherparepvec (T-VEC) in the Treatment of Locally Advanced Cutaneous Angiosarcoma|
|Actual Study Start Date :||April 15, 2019|
|Estimated Primary Completion Date :||May 1, 2021|
|Estimated Study Completion Date :||May 1, 2022|
Experimental: Intralesional injection of T-VEC
Participants will undergo intralesional injections of up to 4 cc of 10^6 plaque-forming units (PFU)/mL of T-VEC. Dose is dependent on the diameter of the lesions to be injected (volume injected is related to diameter of lesion(s) at time point 0). Three weeks later and every other week thereafter, the participants will be injected with up to 4 cc of 10^8 PFU/mL, with dose dependent on the diameter of the lesion(s) to be injected. Participants may be treated for up to 12 months.
Participants will receive intralesional injections of T-VEC of up to 4cc. Dosing of T-VEC is dependent of the size of the lesion.
- Overall Response Rate [ Time Frame: at 24 Weeks ]Overall response rate is defined as the proportion of patients who demonstrate complete or partial responses in injected lesions per modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria appropriate for cutaneous neoplasms (ORR=complete response + partial response).
- Duration of response [ Time Frame: at 4 weeks ]
Response duration will be measured from the time of initial partial response or complete response until documented progression.
The duration of overall response is measured from the time measurement criteria are met for Complete Response or Partial Response (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started).
- Progression-free Survival [ Time Frame: up to 2 years ]Progression-free survival is defined as the period of time from the first injection to progression of disease or appearance of new cutaneous angiosarcomas that were not present at the time of study entry
- Complete Response Rate [ Time Frame: Baseline to 2 years ]Complete response rate is defined as the proportion of participants that have lesions with complete clinical regression
- Adverse Events after T-VEC injections [ Time Frame: Baseline to 2 years ]Monitoring Adverse Events after participants receive injections of T-VEC into Cutaneous Angiosarcoma
- T-VEC treated tumors requiring surgical resection [ Time Frame: Baseline to 2 years ]Measuring the rate of participants requiring surgical resection of T-VEC treated lesions
- Analyses of immune infiltration within resected tumor specimens [ Time Frame: Baseline to 2 years ]Measuring the degree of immune infiltration in surgically resected T-VEC treated tumors
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03921073
|United States, Florida|
|H. Lee Moffitt Cancer Center and Research Institute||Recruiting|
|Tampa, Florida, United States, 33612|
|Contact: Soha Riad 813-745-4780 Soha.Riad@moffitt.org|
|Principal Investigator: John Mullinax, MD|
|Principal Investigator:||John Mullinax, MD,||H. Lee Moffitt Cancer Center and Research Institute|