Brief Title
Intrapleural Gene Transfer for Pleural Mesothelioma
Official Title
A Pilot Study of Repeated Dose Intrapleural Adenoviral-Mediated Interferon-Alpha (SCH 721015, Ad.hIFN-a2b) Gene Transfer for Malignant Pleural Mesothelioma
Brief Summary
This research will study how to activate the immune system by using gene transfer. Gene
transfer involves inserting a specially designed gene into cancer cells. A gene is a part of
the genetic code that instructs the cells of our bodies to produce specific compounds
(proteins) important for the makeup or function of the cell. The study hypothesis is that
repeated doses of SCH 721015 given over a three day interval would result in gene transfer.
Detailed Description
Ad.hIFN-α (SCH 721015, adenoviral-mediated interferon alpha) is a replication-defective
recombinant adenoviral vector containing the human interferon-alpha (hIFN-alpha) gene. This
Phase I study is designed to evaluate the safety and maximum tolerated dose (MTD) of two
doses of Ad.hIFN-alpha injected into the pleural (intrapleural, IP) and given 4 days apart in
subjects with pleural mesothelioma.
Subjects who meet eligibility will have a pleural catheter placed 2 weeks prior to the first
dose. Subjects are then admitted to the research center on Days 1 and 4 for dosing and
overnight observation. Subjects are then followed-up as outpatients for a total of 6 months.
Radiographic evaluations are repeated on Day 64 and at 6 months. The pleural catheter is
removed once it is not necessary.
Study Phase
Phase 1
Study Type
Interventional
Primary Outcome
To analyze gene transfer with two does separated by three-day interval
Condition
Malignant Pleural Mesothelioma
Intervention
SCH 721015
Study Arms / Comparison Groups
Dose Level 1
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Biological
Estimated Enrollment
13
Start Date
February 2009
Completion Date
May 2015
Primary Completion Date
May 2015
Eligibility Criteria
Inclusion Criteria:
- evidence of progressive disease after standard first line treatment of mesothelioma;
OR patient has refused standard first line treatment of mesothelioma
- evaluable disease
- No radiotherapy and/or treatment with chemotherapeutic, cytotoxic, or immunologic
agents within 14 days prior to infusion of the IFN-α vector
- Must have a pleural space involved with tumor accessible for pleural catheter
insertion
- FEV1> 1 liter or 40% of predicted value
- Must have an anti-adenoviral neutralizing antibody titer equal to or less than 1:1000.
This will be measured by the Penn Vector Core
Exclusion Criteria:
- Presence of HIV or Hepatitis B infection
- Use of concurrent systemic steroids, immunosuppressives, or any other medications that
can directly or indirectly suppress the immune system
- Presence of any other life-threatening illness, such as unstable angina, severe oxygen
dependence, significant chronic obstructive pulmonary disease (COPD), end stage liver
or renal disease
- Presence of untreated brain metastases
- Prior bone marrow or stem cell transplants
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Daniel Sterman, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT01212367
Organization ID
UPCC 18508; 808806
Secondary IDs
P01CA066726
Responsible Party
Sponsor
Study Sponsor
Abramson Cancer Center of the University of Pennsylvania
Collaborators
National Cancer Institute (NCI)
Study Sponsor
Daniel Sterman, Principal Investigator, University of Pennsylvania
Verification Date
September 2015