Intrapleural Gene Transfer for Pleural Mesothelioma

A Pilot Study of Repeated Dose Intrapleural Adenoviral-Mediated Interferon-Alpha (SCH 721015, Ad.hIFN-a2b) Gene Transfer for Malignant Pleural Mesothelioma

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01212367

Acronym

IFN-alpha

Enrollment

Registered

2010-09-30

Start date

2009-02-28

Completion date

2015-05-31

Last updated

2015-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malignant Pleural Mesothelioma

Keywords

Gene transfer, Immunology, Cancer

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.

Interventions

BIOLOGICALSCH 721015

1.0 x 10e12 viral particles on Days 1 and 4

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
To analyze gene transfer with two does separated by three-day interval	After the first dose and at each visit until day 94

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026