Intrapleural Gene Transfer for Pleural Mesothelioma (IFN-alpha)

October 4, 2010

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.

Primary Outcome Measures:

To analyze gene transfer with two does separated by three-day interval [ Time Frame: After the first dose and at each visit until day 94 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Identify the maximum tolerated dose of SCH 721015 separated by a three day interval [ Time Frame: On going throughout the conduct of the trial ] [ Designated as safety issue: Yes ]

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

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