A Phase III, Open Label, Randomized, Parallel Group Study to Evaluate the Efficacy and Safety of Intrapleural Administration of Adenovirus-Delivered Interferon Alpha-2b (rAd-IFN) in Combination with Celecoxib and Gemcitabine in Patients with Malignant Pleural Mesothelioma
- Conditions
- Malignant pleural mesothelionapleural cancer10038666
- Registration Number
- NL-OMON48042
- Lead Sponsor
- Trizell Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 11
1. Aged 18 years or older and able to give informed consent;
2. Confirmed histological diagnosis of MPM with histological type epithelioid
or biphasic (predominantly [*50%] epithelioid);
3. Measurable disease, per modified RECIST for pleural mesothelioma;
4. Has failed a minimum of 1 treatment regimen and a maximum of 2 treatment
regimens, which may have been chemotherapeutic and/or immunotherapeutic
treatment regimens for MPM which included at least 1 anti-folate and platinum
combination regimen;
5. Has a pleural space accessible for pleural catheter insertion. Patients with
a previously inserted pleural catheter may enroll, and the pre-existing
catheter can be used for vector administration as long as it is functional and
has no evidence of local infection;
6. Life expectancy *12 weeks in the judgement of the Investigator;
7. ECOG status of 1 or 0;
8. Female and male patients:
- Female patients must be either postmenopausal (no menstrual period for a
minimum of 12 months) or surgically sterile upon entry into the study. Female
patients of childbearing potential must have a negative pregnancy test upon
entry into this study and agree to use a highly effective method of
contraception from Screening until 1 month following administration of
gemcitabine;
- Male patients must be either surgically sterile or agree to use a
double-barrier contraception method from Screening until 1 month
post-gemcitabine administration;
9. Adequate laboratory values at screening
1. Is *treatment-naïve* (i.e., has not received at least 1 anti-folate and
platinum combination regimen);
2. Has previously received 3 or more lines of systemic chemotherapeutic or
immunotherapeutic treatment;
3. Has previously received treatment with gemcitabine;
4.Has stage IV extrathoracic metastatic disease;
5.Inadequate pulmonary function of clinical significance as per Investigator
review;
6.Clinically significant pericardial effusion at Screening;
7.Prior therapy(ies), if applicable, must be completed according to the
protocol-specified criteria
8.Patient previously treated with IFNs (e.g., for chronic active hepatitis);
9.Suspected/known hypersensitivity to IFN-*2b;
10. Known hypersensitivity to celecoxib or sulfonamides;
11. Impaired cardiac function or clinically significant cardiac disease;
12. Women who are pregnant or breastfeeding;
13. Uncontrolled intercurrent illness
14. Patients with active, known, or suspected auto-immune disease or a syndrome
that requires systemic or immunosuppressive agents (oral prednisolone or
equivalent at a dose of <=10 mg per day is permitted);
15. History of asthma, urticaria, or other allergic-type reactions after taking
aspirin or other NSAIDs;
16. History of ulcer disease or gastrointestinal bleeding;
17. Uncontrolled or poorly controlled hypertension requiring 3 or more
anti-hypertensive drugs;
18. Patients receiving lithium;
19. Any significant disease which, in the opinion of the Investigator, would
place the patient at increased risk of harm if he/she participated in the study;
20. History of malignancy of other organ system within the past 5 years, except
treated basal cell or squamous cell carcinoma of the skin, or early stage
prostate cancer (stage T2a or smaller, prostate specific antigen <=10 ng/mL,
Gleason score <=6); or
21. Has a congenital or acquired immunodeficiency, including patients with
known history of infection with human immunodeficiency virus.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint is OS, defined as time to death (from any cause) from<br /><br>randomization. </p><br>
- Secondary Outcome Measures
Name Time Method