About Bolder Science

Our mission is to provide healthcare professionals with unbiased clinical research information, easily.

Currently, you can access the following clinical trials being conducted worldwide:

378040 studies
in
220 countries
Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/14/2021.
This website is for US healthcare professionals

Log In to Bolder Science

or

Don't have an account? Sign Up

Please enter your email address.

You will receive a link to create a new password via email.

Log In

Create an Account

or
(optional) ?

Welcome, !

Please complete the following 4 questions to ensure you receive the information that best suits your needs.

Clinical Trials of Interest

When I’m looking for information on clinical trials, I usually am interested in...

finding clinical trials in which to enroll my patients

Rarely Often

finding newly launched clinical trials (for all phases)

Rarely Often

updates on status changes for clinical trials

Rarely Often

pipeline molecules

Rarely Often

Drug Interventions

Enter up to 3 drug interventions you are currently interested in:

Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/14/2021.

Study of T-VEC in Locally Advanced Cutaneous Angiosarcoma

Clinicaltrials.gov identifier NCT03921073

Recruitment Status Recruiting

First Posted April 19, 2019

Last update posted April 8, 2021

Study Description

Brief summary:

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

  • Condition or Disease:Angiosarcoma of Skin
  • Intervention/Treatment: Drug: T-VEC
  • Phase: Phase 2
Detailed Description

N/A

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 15 participants
  • 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 2019
  • Estimated Primary Completion Date: May 2021
  • Estimated Study Completion Date: May 2022
Arms and interventions
Arm Intervention/treatment
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.
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.
Outcome Measures
  • Primary Outcome Measures: 1. 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).
  • Secondary Outcome Measures: 1. 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).
  • 2. 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
  • 3. 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
  • 4. 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
  • 5. 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
  • 6. 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
Eligibility Criteria
  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
Criteria

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 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.

Contacts and Locations
Contacts
Locations

United States, Florida
H. Lee Moffitt Cancer Center and Research Institute
Tampa

Sponsors and Collaborators

H. Lee Moffitt Cancer Center and Research Institute

Investigators

Principal Investigator: John Mullinax, MD, H. Lee Moffitt Cancer Center and Research Institute

More Information
  • Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
  • ClinicalTrials.gov Identifier: NCT03921073 History of Changes
  • Other Study ID Numbers: MCC-19878
  • First Posted: April 19, 2019 Key Record Dates
  • Last Update Posted: April 8, 2021
  • Last Verified: April 2021
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by H. Lee Moffitt Cancer Center and Research Institute: Skin
    Angiosarcoma
    Cutaneous
  • Additional relevant MeSH terms: Hemangiosarcoma