Malignant Pleural MesotheliomaPhase 1/21716-12NCT01721018
Intrapleural Administration of HSV1716 to Treat Patients With Malignant Pleural Mesothelioma.
A Phase 1/2 study testing HSV1716 Intra-pleural delivery in people with Malignant Pleural Mesothelioma, run by Virttu Biologics Limited at 2 sites in United Kingdom.
Trial summary
HSV1716, an oncolytic virus, is a mutant herpes simplex virus (HSV) type I, deleted in the RL1 gene which encodes the protein ICP34.5. Malignant mesothelioma is an aggressive, asbestos-related tumour of the pleural and peritoneal cavities. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Pleural Mesothelioma
- What is being tested?
- HSV1716 Intra-pleural delivery
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Oct 2012to 14 Nov 2016
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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
- Patients with histologically proven malignant pleural mesothelioma
- Patients with disease which is not amenable to potentially curative resection
- Patients with pleural effusions and/or 'trapped lung' who (i) have an existing indwelling pleural catheter for draining of excess pleural fluid or (ii) who require the insertion of an indwelling pleural catheter to drain excess pleural fluid
- Patients with a performance status ≤ 2 (ECOG)
- Age of ≥ 18 years (at screening)
- Ability to give written informed consent as evidenced by signature on the patient consent form, to communicate well with the investigator and to comply with the expectations of the study
Who cannot join
- Patients likely to require palliative radio- or chemotherapy within 30 days
- Any evidence of uncontrolled cardiac or respiratory disease that would be a contra-indication for virus administration
- Any other serious medical or psychiatric disorder that would be a contra-indication for virus administration
- Acute active infection of any kind or other severe systemic disease or medical or surgical condition that is deemed significant by the principal investigator
- Patients with immunosuppressive disorders or on systemic steroids > 5mg prednisolone/day
- Pregnancy: women of childbearing potential not taking adequate contraception, and women who are breast feeding
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- Previous treatment with investigational viral therapy products
- Administration of any unlicensed or investigational product within 8 weeks of entry to the study
- No prior or concurrent malignancy within 5 years other than basal cell carcinoma of the skin or in situ neoplasia of the cervix uteri
- Inadequate haematological function as defined by:
- Haemoglobin (Hb) < 10g/dl, Neutrophil Count < 1.5 x 10e9/l, Platelets < 100 x 10e9/l
- Deranged liver function tests: serum bilirubin ≥ 1.5 x upper limit of normal reference range for laboratory; transaminases ≥ 5 x upper limit of normal reference range
- Patients with inadequate renal function: serum creatinine ≥ 1.5 x upper limit of reference range for laboratory
- Patients whose indwelling catheter is not of the type approved by the sponsor for use in the study
- Outwith any of the inclusion criteria above or considered unsuitable for entry into the study in any other way at the discretion of the principal investigator
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Queen Elizabeth Univeristy Hospital, NHS Greater Glasgow & Clyde Health Board
Glasgow, G51 4TF
Weston Park Hospital, Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, South Yorkshire, S10 2SJ
About this study
Official title: A Phase I/IIa Study of the Safety, Tolerability and Biological Effect of Single and Repeat Administration of the Selectively Replication-competent Herpes Simplex Virus HSV1716 Into the Tumor-bearing Pleural Cavity (Intrapleural) in Patients With Inoperable Malignant Pleural Mesothelioma.
HSV1716, an oncolytic virus, is a mutant herpes simplex virus (HSV) type I, deleted in the RL1 gene which encodes the protein ICP34.5.
Malignant mesothelioma is an aggressive, asbestos-related tumour of the pleural and peritoneal cavities. It is a rare cancer which occurs in individuals who have been exposed to asbestos, although it typically occurs decades after exposure (10-40 years later). Malignant pleural mesothelioma forms plaques that are distributed on the surface of the pleural space in the lung. Approximately 30% of patients require an indwelling pleural catheter for drainage of pleural effusions. In this patient group, the indwelling catheter may be used to facilitate loco-regional delivery of HSV1716 to the pleural space.
This study seeks to evaluate the safety and biological effects of single and multiple administrations of HSV1716 in the treatment of malignant pleural mesothelioma.
Read the detailed description
The study will be conducted in two parts. PART A is a single centre, single dose design, open label. Patients with inoperable malignant pleural mesothelioma will receive a single dose of HSV1716 by intrapleural administration. Delivery will be by direct administration via an indwelling catheter into the pleural cavity. PART B is a single centre, repeat dose design, open label. Two groups of three patients with inoperable malignant pleural mesothelioma will receive 2 (group 1) or 4 (group 2) single doses of HSV1716 at weekly intervals. Administration will be via an indwelling catheter into the pleural cavity.
- Conditions
- Malignant Pleural Mesothelioma
- Being tested
- HSV1716 Intra-pleural delivery
- Keywords
- Oncolytic virus, HSV1716, Mesothelioma, MPM, Woll, Sheffield, Weston Park, Virttu, Crusade
- Medical subject headings
- Mesothelioma, Malignant, Mesothelioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HSV1716 Intra-pleural deliveryBiological
Also called Seprehvir
| Study group | Role | What they receive |
|---|---|---|
| HSV1716 | Experimental | Single Arm Phase I/II study of intra-pleural HSV1716 administration. Receives: Biological: HSV1716 Intra-pleural delivery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of HSV1716 given by single and repeat intrapleural administration in patients with inoperable malignant pleural mesothelioma.
Measured: Dose limiting toxicities will be assessed at 28 days after last injection of HSV1716.
Secondary outcomes (1)
Obtain evidence of HSV1716 replication and lysis of malignant pleural mesothelioma cells through analysis of pleural fluid and serum samples for evidence of cell death and/or HSV1716 replication and/or changes in appropriate biomarkers.
Measured: Samples will be collected at each outpatient visit up to day 29 (Part A), or day 50 (Part B).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2012 (estimated)
- Study startOct 2012
- Primary completion14 Nov 2016
- Study completion14 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Pleural MesotheliomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virttu Biologics Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Penella J Woll, MB BS PhD FRCP, Principal investigator, Sheffield Teaching Hospitals NHS Foundation Trust, Weston Park Hospital, Sheffield, S10 2SJ, UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01721018
- Sponsor's protocol ID
- 1716-12
- Acronym
- 1716-12
- Status last verified
- Jun 2017
- First submitted
- 22 Oct 2012
- Last updated
- 9 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/IIa Study of the Safety, Tolerability and Biological Effect of Single and Repeat Administration of the Selectively Replication-competent Herpes Simplex Virus HSV1716 Into the Tumor-bearing Pleural Cavity (Intrapleural) in Patients With Inoperable Malignant Pleural Mesothelioma.
- ClinicalTrials.gov ID
- NCT01721018
- Acronym / sponsor ID
- 1716-12 / 1716-12
- Conditions
- Malignant Pleural Mesothelioma
- Keywords
- Oncolytic virus, HSV1716, Mesothelioma, MPM, Woll, Sheffield, Weston Park, Virttu
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Virttu Biologics LimitedIndustry (pharma, biotech, devices)
- Study start
- Oct 2012
- Primary completion
- 14 Nov 2016 (actual)
- Study completion
- 14 Nov 2016 (actual)
- First posted
- 2 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
HSV1716, an oncolytic virus, is a mutant herpes simplex virus (HSV) type I, deleted in the RL1 gene which encodes the protein ICP34.5.
Malignant mesothelioma is an aggressive, asbestos-related tumour of the pleural and peritoneal cavities. It is a rare cancer which occurs in individuals who have been exposed to asbestos, although it typically occurs decades after exposure (10-40 years later). Malignant pleural mesothelioma forms plaques that are distributed on the surface of the pleural space in the lung. Approximately 30% of patients require an indwelling pleural catheter for drainage of pleural effusions. In this patient group, the indwelling catheter may be used to facilitate loco-regional delivery of HSV1716 to the pleural space.
This study seeks to evaluate the safety and biological effects of single and multiple administrations of HSV1716 in the treatment of malignant pleural mesothelioma.
Detailed description
The study will be conducted in two parts. PART A is a single centre, single dose design, open label. Patients with inoperable malignant pleural mesothelioma will receive a single dose of HSV1716 by intrapleural administration. Delivery will be by direct administration via an indwelling catheter into the pleural cavity. PART B is a single centre, repeat dose design, open label. Two groups of three patients with inoperable malignant pleural mesothelioma will receive 2 (group 1) or 4 (group 2) single doses of HSV1716 at weekly intervals. Administration will be via an indwelling catheter into the pleural cavity.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HSV1716 | Experimental | Biological: HSV1716 Intra-pleural deliverySingle Arm Phase I/II study of intra-pleural HSV1716 administration. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with histologically proven malignant pleural mesothelioma
- Patients with disease which is not amenable to potentially curative resection
- Patients with pleural effusions and/or 'trapped lung' who (i) have an existing indwelling pleural catheter for draining of excess pleural fluid or (ii) who require the insertion of an indwelling pleural catheter to drain excess pleural fluid
- Patients with a performance status ≤ 2 (ECOG)
- Age of ≥ 18 years (at screening)
Key exclusion criteria (15 listed)
- Patients likely to require palliative radio- or chemotherapy within 30 days
- Any evidence of uncontrolled cardiac or respiratory disease that would be a contra-indication for virus administration
- Any other serious medical or psychiatric disorder that would be a contra-indication for virus administration
- Acute active infection of any kind or other severe systemic disease or medical or surgical condition that is deemed significant by the principal investigator
- Patients with immunosuppressive disorders or on systemic steroids > 5mg prednisolone/day
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HSV1716 Intra-pleural deliveryAlso: Seprehvir | Biological | HSV1716 |
Primary outcome
Safety and tolerability of HSV1716 given by single and repeat intrapleural administration in patients with inoperable malignant pleural mesothelioma.
Time frame: Dose limiting toxicities will be assessed at 28 days after last injection of HSV1716.
1 secondary outcome
Obtain evidence of HSV1716 replication and lysis of malignant pleural mesothelioma cells through analysis of pleural fluid and serum samples for evidence of cell death and/or HSV1716 replication and/or changes in appropriate biomarkers.
Time frame: Samples will be collected at each outpatient visit up to day 29 (Part A), or day 50 (Part B).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Penella J Woll, MB BS PhD FRCP principal investigator
Sheffield Teaching Hospitals NHS Foundation Trust, Weston Park Hospital, Sheffield, S10 2SJ, UK
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing HSV1716 Intra-pleural delivery in people with Malignant Pleural Mesothelioma, run by Virttu Biologics Limited at 2 sites in United Kingdom.
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 6 inclusion and 15 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: finished, as of the sponsor's last update on 9 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Safety and tolerability of HSV1716 given by single and repeat intrapleural administration in patients with inoperable malignant pleural mesothelioma. (time frame: Dose limiting toxicities will be assessed at 28 days after last injection of HSV1716.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Jun 2017.