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Angiosarcoma of SkinPhase 2NCT03921073

Study of T-VEC in Locally Advanced Cutaneous Angiosarcoma

A Phase 2 study testing T-VEC in people with Angiosarcoma of Skin, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This is a single-arm study evaluating the efficacy of injecting Talimogene Laherparepvec T-VEC into Cutaneous Angiosarcoma tumors. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Angiosarcoma of Skin
What is being tested?
T-VEC
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5 participants
Where
1 siteUnited States
Study dates
20 Aug 2019to 28 Sep 2021
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
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  • 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 and injection does not involve a visceral lesion
  • Coagulation
  • International normalization ratio (INR) or prothrombin time (PT) ≤1.5 x ULN, unless the subject is receiving anticoagulant therapy, in which case PT and partial thromboplastin time (PTT)/ activated PTT (aPTT) must be within therapeutic range of intended use of anticoagulants.
  • PTT or aPTT ≤1.5 x ULN, unless the subject is receiving anticoagulant therapy as long as PT and PTT/aPTT is within therapeutic range of intended use of anticoagulants.- Female subjects of childbearing potential should have a negative urine or serum pregnancy test within 72 hours prior to enrollment. If urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.

Who cannot join

  • Participants with a second active malignancy, exceptions are localized non-melanoma skin cancers or in situ carcinoma
  • Participants receiving any other investigational agents
  • Participants with tumor(s) in direct contact or encasing a major blood vessel, those with ulceration and/or fungation onto the skin surface, and those with history of re-irradiation or prior lymph node neck dissection to a field involving the carotid arteries
  • History or evidence of active autoimmune disease that requires systemic treatment (ie, with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
  • Evidence of clinically significant immunosuppression such as the following:
  • Primary immunodeficiency state such as Severe Combined Immunodeficiency Disease.
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  • concurrent opportunistic infection.
  • receiving systemic immunosuppressive therapy (> 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • H. Lee Moffitt Cancer Center and Research Institute

    Tampa, Florida, 33612

Other trials in United States

About this study

Official title: A Phase II Study of Talimogene Laherparepvec (T-VEC) in the Treatment of Locally Advanced Cutaneous Angiosarcoma

This is a single-arm study evaluating the efficacy of injecting Talimogene Laherparepvec T-VEC into Cutaneous Angiosarcoma tumors.

Being tested
T-VEC
Keywords
Cutaneous, Angiosarcoma, Skin
Medical subject headings
Hemangiosarcoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • T-VECDrug

    Participants will receive intralesional injections of T-VEC of up to 4cc. Dosing of T-VEC is dependent of the size of the lesion.

Study groups in NCT03921073
Study groupRoleWhat they receive
Intralesional injection of T-VECExperimentalParticipants 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.
Receives: Drug: T-VEC

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Response Rate

    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).

    Measured: at 24 Weeks

Secondary outcomes (5)

  1. Duration of Response

    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).

    Measured: at 4 weeks

  2. Progression-free Survival

    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

    Measured: up to 2 years

  3. Complete Response Rate

    Complete response rate is defined as the proportion of participants that have lesions with complete clinical regression

    Measured: Baseline to 2 years

  4. T-VEC Treated Tumors Requiring Surgical Resection

    Measuring the rate of participants requiring surgical resection of T-VEC treated lesions

    Measured: Baseline to 2 years

  5. Analyses of Immune Infiltration Within Resected Tumor Specimens

    Measuring the degree of immune infiltration in surgically resected T-VEC treated tumors

    Measured: Baseline to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Apr 2019
  2. Study start20 Aug 2019
  3. Primary completion28 Sep 2021
  4. Study completion28 Sep 2021

Why it stopped: Sponsor Terminated Funding

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
5 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03921073
Sponsor's protocol ID
MCC-19878
Status last verified
Oct 2022
First submitted
15 Apr 2019
Last updated
1 Nov 2022
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing T-VEC in people with Angiosarcoma of Skin, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 1 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Nov 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Response Rate (time frame: at 24 Weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03921073.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2022.

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