Pleural MesotheliomaPhase 1NCT00299962
Gene Therapy for Pleural Malignancies
A Phase 1 study testing Adenoviral-mediated Interferon-beta and SCH 721015 in people with Pleural Mesothelioma and Metastatic Pleural Effusions, run by University of Pennsylvania at 1 site in United States.
Trial summary
This Phase I study will evaluate the safety of two doses of BG00001 at different doses and intervals. Eligible subjects will have: malignant pleural mesothelioma, or pleural effusions who have progressed through at least one prior therapy or have refused therapy BG00001 is given twice through a catheter in the pleural… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pleural Mesothelioma, Metastatic Pleural Effusions
- What is being tested?
- Adenoviral-mediated Interferon-beta and SCH 721015
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2006to Oct 2009
- Phase
- Phase 1
- 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
- must have malignant pleural effusion from mesothelioma or metastatic from primary lung, breast, gastrointestinal, genitourinary, melanoma, or sarcoma
- must have evaluable disease
- must have ECOG performance status of 2
- must have pleural space involved with tumor accessible for pleural catheter
- must have FEV1 > 1 liter or 40% of predicted value
- must have completed radiotherapy and/or treatment with chemotherapy, cytotoxic, or immunologic agents 4 weeks prior to dosing with BG00001
Show all 9Show fewer
- concurrent Tarceva is allowed if patients has been on a stable dose for at least three months and has not had serious adverse events
- patients on stable dose of hormone may continue use of hormone
- patients on stable dose of Tarceva for 3 months and without complications may remain on Tarceva
Who cannot join
- malignant pleural effusions secondary to lymphoma
- rapidly re-accumulating, symptomatic malignant pleural effusions that require immediate mechanical or chemical pleurodesis for palliation
- untreated brain metastases
- use of concurrent systemic steroids or immunosuppressants
Trial locations and contacts
1 site in 1 country.
United States1 site
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: A Phase I Clinical Trial of Repeated Dose Intrapleural Adenoviral-Mediated Interferon-beta (BG00001, Ad.hIFN-β for Pleural Malignancies
This Phase I study will evaluate the safety of two doses of BG00001 at different doses and intervals. Eligible subjects will have:
- malignant pleural mesothelioma, or
- pleural effusions who have progressed through at least one prior therapy or have refused therapy
BG00001 is given twice through a catheter in the pleural space.
Read the detailed description
Ad.hIFN-β (BG00001) is a replication-defective recombinant adenoviral vector containing the human interferon-beta (hIFN-β) gene. This Phase I study is designed to evaluate the safety and maximum tolerated dose (MTD) of two doses of intrapleural (IP) Ad.hIFN-β in subjects with pleural malignancies either metastatic or pleural mesothelioma.
Five dose levels will be studied:
- Dose levels 1, 2, and 3 will be given on Days 1 and 15
- Dose levels 4 and 5 will be given on Days 1 and 8
- Conditions
- Pleural Mesothelioma, Metastatic Pleural Effusions
- Being tested
- Adenoviral-mediated Interferon-beta, SCH 721015
- Keywords
- gene therapy, immunotherapy
- Medical subject headings
- Mesothelioma, Malignant, Pleural Effusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adenoviral-mediated Interferon-betaBiological
BG00001 at doses 1.5 x 10e12 and 3 x 10e12 viral particles Days 1 and 8
SCH 721015Biological
Also called Adenoviral-mediated Interferon-beta, Ad.hIFN-beta
Comparison of different doses and frequency of investigational agent
| Study group | Role | What they receive |
|---|---|---|
| Dose level 4 | Experimental | Not described Receives: Biological: Adenoviral-mediated Interferon-beta; Biological: SCH 721015 |
| Dose level 5 | Experimental | Not described Receives: Biological: Adenoviral-mediated Interferon-beta; Biological: SCH 721015 |
| Dose Level 1 | Experimental | on Days 1 and 15 Receives: Biological: SCH 721015 |
| Dose Level 2 | Experimental | On Days 1 and 15 Receives: Biological: SCH 721015 |
| Dose Level 3 | Experimental | On Days 1 and 15 Receives: Biological: SCH 721015 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine toxicity of two doses of intrapleural BG00001 (Ad.hIFN-β over 8 days, and
Measured: Through Day 85
Secondary outcomes (2)
To assess systemic and intrapleural cytokine responses as well as cellular and humoral immune responses after repeated BG00001 instillation,
Measured: Through Day 85
and to assess, in a preliminary way, efficacy via tumor regression, time to progression and survival.
Measured: 15 years or until subject dies, whichever comes first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2006 (estimated)
- Study startMar 2006
- Primary completionMay 2008
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pleural MesotheliomaStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Biogen
- Responsible party
- Sponsor
- Investigators
- Daniel H. Sterman, M.D., Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00299962
- Sponsor's protocol ID
- 803776
- Other IDs
- P01CA066726
- Status last verified
- Mar 2020
- First submitted
- 3 Mar 2006
- Last updated
- 18 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Trial of Repeated Dose Intrapleural Adenoviral-Mediated Interferon-beta (BG00001, Ad.hIFN-β for Pleural Malignancies
- ClinicalTrials.gov ID
- NCT00299962
- Acronym / sponsor ID
- 803776
- Conditions
- Pleural Mesothelioma, Metastatic Pleural Effusions
- Keywords
- gene therapy, immunotherapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Biogen
- Study start
- Mar 2006
- Primary completion
- May 2008 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 7 Mar 2006 (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.
This Phase I study will evaluate the safety of two doses of BG00001 at different doses and intervals. Eligible subjects will have:
- malignant pleural mesothelioma, or
- pleural effusions who have progressed through at least one prior therapy or have refused therapy
BG00001 is given twice through a catheter in the pleural space.
Detailed description
Ad.hIFN-β (BG00001) is a replication-defective recombinant adenoviral vector containing the human interferon-beta (hIFN-β) gene. This Phase I study is designed to evaluate the safety and maximum tolerated dose (MTD) of two doses of intrapleural (IP) Ad.hIFN-β in subjects with pleural malignancies either metastatic or pleural mesothelioma.
Five dose levels will be studied:
- Dose levels 1, 2, and 3 will be given on Days 1 and 15
- Dose levels 4 and 5 will be given on Days 1 and 8
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Dose level 4 | Experimental | Biological: Adenoviral-mediated Interferon-beta, Biological: SCH 721015 |
| Dose level 5 | Experimental | Biological: Adenoviral-mediated Interferon-beta, Biological: SCH 721015 |
| Dose Level 1 | Experimental | Biological: SCH 721015on Days 1 and 15 |
| Dose Level 2 | Experimental | Biological: SCH 721015On Days 1 and 15 |
| Dose Level 3 | Experimental | Biological: SCH 721015On Days 1 and 15 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- must have malignant pleural effusion from mesothelioma or metastatic from primary lung, breast, gastrointestinal, genitourinary, melanoma, or sarcoma
- must have evaluable disease
- must have ECOG performance status of 2
- must have pleural space involved with tumor accessible for pleural catheter
- must have FEV1 > 1 liter or 40% of predicted value
Key exclusion criteria (4 listed)
- malignant pleural effusions secondary to lymphoma
- rapidly re-accumulating, symptomatic malignant pleural effusions that require immediate mechanical or chemical pleurodesis for palliation
- untreated brain metastases
- use of concurrent systemic steroids or immunosuppressants
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 |
|---|---|---|
| Adenoviral-mediated Interferon-betaBG00001 at doses 1.5 x 10e12 and 3 x 10e12 viral particles Days 1 and 8 | Biological | Dose level 4, Dose level 5 |
| SCH 721015Also: Adenoviral-mediated Interferon-beta, Ad.hIFN-betaComparison of different doses and frequency of investigational agent | Biological | Dose Level 1, Dose Level 2, Dose Level 3, Dose level 4, Dose level 5 |
Primary outcome
To determine toxicity of two doses of intrapleural BG00001 (Ad.hIFN-β over 8 days, and
Time frame: Through Day 85
2 secondary outcomes
To assess systemic and intrapleural cytokine responses as well as cellular and humoral immune responses after repeated BG00001 instillation,
Time frame: Through Day 85
and to assess, in a preliminary way, efficacy via tumor regression, time to progression and survival.
Time frame: 15 years or until subject dies, whichever comes first
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 18 Mar 2020.
Related trials for Pleural Mesothelioma
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
RecruitingPhase 1
SW-682 in Advanced Solid Tumors
Advanced Solid Tumor, Mesothelioma, Malignant
Active, not recruitingPhase 1
Mesothelin-targeted CAR T-cell Therapy in Patients With Mesothelioma
Malignant Pleural Mesothelioma (MPM)
RecruitingPhase 1/2
Efficacy and Safety of Ivonescimab Plus Pemetrexed and Platinum-Based Chemotherapy in Advanced Malignant Pleural Mesothelioma
Malignant Pleural Mesothelioma, Advanced
RecruitingObservational study
Solid Tumor Analysis for HLA Loss of Heterozygosity (LOH) and Apheresis for CAR T- Cell Manufacturing
Solid Tumor, Adult, Colorectal Cancer
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.
Daniel H. Sterman, M.D. principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Adenoviral-mediated Interferon-beta and SCH 721015 in people with Pleural Mesothelioma and Metastatic Pleural Effusions, run by University of Pennsylvania 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 9 inclusion and 4 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 18 Mar 2020. 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 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.
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?
To determine toxicity of two doses of intrapleural BG00001 (Ad.hIFN-β over 8 days, and (time frame: Through Day 85). 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 18 Mar 2020.