Intrapleural Gene Transfer for Pleural Mesothelioma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2015-05-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Malignant Pleural Mesothelioma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dose Level 1

Group Type EXPERIMENTAL

SCH 721015

Intervention Type BIOLOGICAL

1.0 x 10e12 viral particles on Days 1 and 4

Dose Level 2

This is a dose de escalation.

Group Type EXPERIMENTAL

SCH 721015

Intervention Type BIOLOGICAL

3.0 x 10e11 viral particles on Days 1 and 4

Interventions

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SCH 721015

1.0 x 10e12 viral particles on Days 1 and 4

Intervention Type BIOLOGICAL

SCH 721015

3.0 x 10e11 viral particles on Days 1 and 4

Intervention Type BIOLOGICAL

Other Intervention Names

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Adenoviral-mediated Interferon-alpha Ad.IFN-alpha Adenoviral-mediated Interferon-alpha Ad.IFN-alpha

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No