- Solid Tumors
- Pipeline Molecules
- Alliance Partners
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Currently, you can access the following clinical trials being conducted worldwide:
Clinicaltrials.gov identifier NCT03921073
Recruitment Status Recruiting
First Posted April 19, 2019
Last update posted April 8, 2021
This is a single-arm study evaluating the efficacy of injecting Talimogene Laherparepvec T-VEC into Cutaneous Angiosarcoma tumors.
|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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, , Learn About Clinical Studies.-->
- 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:
- 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
- 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).
- 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 2 weeks) including oral steroid doses
> 10 mg/day of prednisone or equivalent within 7 days prior to enrollment.
- Active herpetic skin lesions or prior complications of HSV-1 infection (e.g., herpetic
keratitis or encephalitis).
- Requires intermittent or chronic systemic (intravenous or oral) treatment with an
antiherpetic drug (e.g., acyclovir), other than intermittent topical use.
- Previous treatment with talimogene laherparepvec or any other oncolytic virus.
- Prior therapy with tumor vaccine.
- Received live vaccine within 28 days prior to enrollment.
- Prior immunosuppressive, chemotherapy, radiotherapy (in which the field encompassed a
planned injection site), biological cancer therapy, or major surgery within 28 days
prior to enrollment or has not recovered to CTCAE grade 1 or better from adverse event
due to cancer therapy administered more than 28 days prior to enrollment.
- Prior radiotherapy in which the field does not overlap the injection sites or
non-immunosuppressive targeted therapy within 14 days prior to enrollment or has not
recovered to CTCAE grade 1 or better from adverse event due to cancer therapy
administered more than 14 days prior to enrollment
- Currently receiving treatment with another investigational device or drug study, or < 28 days since ending treatment with another investigational device or drug study(s). - Other investigational procedures while participating in this study are excluded. - Known to have acute or chronic active hepatitis B infection, hepatitis C infection, or human immunodeficiency virus (HIV) infection. - History of other malignancy within the past 5 years with the following exceptions: adequately treated non melanoma skin cancer, cervical carcinoma in situ, breast ductal carcinoma in situ, or prostatic intraepithelial neoplasia without evidence of disease at the time of enrollment - Participant has known sensitivity to talimogene laherparepvec or any of its components to be administered during dosing. - Female subject is pregnant or breast-feeding, or planning to become pregnant during study treatment and through 3 months after the last dose of talimogene laherparepvec. - Female subject of childbearing potential who is unwilling to use acceptable method(s) of effective contraception during study treatment and through 3 months after the last dose of talimogene laherparepvec. - Sexually active subjects and their partners unwilling to use male or female latex condom to avoid potential viral transmission during sexual contact while on treatment and within 30 days after treatment with talimogene laherparepvec. - Participants who are unwilling to minimize exposure with his/her blood or other body fluids to individuals who are at higher risks for HSV-1 induced complications such as immunosuppressed individuals, individuals known to have HIV infection, pregnant women, or infants under the age of 3 months, during talimogene laherparepvec treatment and through 30 days after the last dose of talimogene laherparepvec.
United States, Florida
H. Lee Moffitt Cancer Center and Research Institute
H. Lee Moffitt Cancer Center and Research Institute
Principal Investigator: John Mullinax, MD, H. Lee Moffitt Cancer Center and Research Institute