Condition or disease | Intervention/treatment | Phase |
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Angiosarcoma of Skin | Drug: T-VEC | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 5 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase II Study of Talimogene Laherparepvec (T-VEC) in the Treatment of Locally Advanced Cutaneous Angiosarcoma |
Actual Study Start Date : | August 20, 2019 |
Estimated Primary Completion Date : | September 28, 2021 |
Estimated Study Completion Date : | December 31, 2022 |
Arm | Intervention/treatment |
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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.
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Drug: T-VEC
Participants will receive intralesional injections of T-VEC of up to 4cc. Dosing of T-VEC is dependent of the size of the lesion.
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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).
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Florida | |
H. Lee Moffitt Cancer Center and Research Institute | |
Tampa, Florida, United States, 33612 |
Principal Investigator: | John Mullinax, MD, | H. Lee Moffitt Cancer Center and Research Institute |
Tracking Information | |||||
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First Submitted Date ICMJE | April 15, 2019 | ||||
First Posted Date ICMJE | April 19, 2019 | ||||
Last Update Posted Date | May 24, 2021 | ||||
Actual Study Start Date ICMJE | August 20, 2019 | ||||
Estimated Primary Completion Date | September 28, 2021 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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).
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Study of T-VEC in Locally Advanced Cutaneous Angiosarcoma | ||||
Official Title ICMJE | A Phase II Study of Talimogene Laherparepvec (T-VEC) in the Treatment of Locally Advanced Cutaneous Angiosarcoma | ||||
Brief Summary | This is a single-arm study evaluating the efficacy of injecting Talimogene Laherparepvec T-VEC into Cutaneous Angiosarcoma tumors. | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 2 | ||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Angiosarcoma of Skin | ||||
Intervention ICMJE | Drug: T-VEC
Participants will receive intralesional injections of T-VEC of up to 4cc. Dosing of T-VEC is dependent of the size of the lesion.
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Study Arms ICMJE | 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.
Intervention: Drug: T-VEC
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Active, not recruiting | ||||
Actual Enrollment ICMJE |
5 | ||||
Original Estimated Enrollment ICMJE |
13 | ||||
Estimated Study Completion Date ICMJE | December 31, 2022 | ||||
Estimated Primary Completion Date | September 28, 2021 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03921073 | ||||
Other Study ID Numbers ICMJE | MCC-19878 | ||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | H. Lee Moffitt Cancer Center and Research Institute | ||||
Study Sponsor ICMJE | H. Lee Moffitt Cancer Center and Research Institute | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | H. Lee Moffitt Cancer Center and Research Institute | ||||
Verification Date | May 2021 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |