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Intrapleural Gene Transfer for Pleural Mesothelioma (IFN-alpha)

Primary Purpose

Malignant Pleural Mesothelioma

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

SCH 721015

About this trial

This is an interventional treatment trial for Malignant Pleural Mesothelioma focused on measuring Gene transfer, Immunology, Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

University of Pennsylvania

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Dose Level 1

Dose Level 2

Arm Description

This is a dose de escalation.

Outcomes

Primary Outcome Measures

To analyze gene transfer with two does separated by three-day interval

Secondary Outcome Measures

Full Information

NCT ID

NCT01212367

First Posted

September 29, 2010

Last Updated

September 21, 2015

Sponsor

Abramson Cancer Center at Penn Medicine

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT01212367

Brief Title

Intrapleural Gene Transfer for Pleural Mesothelioma

Acronym

IFN-alpha

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2015

Overall Recruitment Status

Completed

Study Start Date

February 2009 (undefined)

Primary Completion Date

May 2015 (Actual)

Study Completion Date

May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Abramson Cancer Center at Penn Medicine

Collaborators

National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Malignant Pleural Mesothelioma

Keywords

Gene transfer, Immunology, Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

13 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Dose Level 1

Arm Type

Experimental

Arm Title

Dose Level 2

Arm Type

Experimental

Arm Description

This is a dose de escalation.

Intervention Type

Biological

Intervention Name(s)

SCH 721015

Other Intervention Name(s)

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

Intervention Description

1.0 x 10e12 viral particles on Days 1 and 4

Intervention Type

Biological

Intervention Name(s)

SCH 721015

Other Intervention Name(s)

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

Intervention Description

3.0 x 10e11 viral particles on Days 1 and 4

Primary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Daniel Sterman

Organizational Affiliation

University of Pennsylvania

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Pennsylvania

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

21642245

Citation

Sterman DH, Haas A, Moon E, Recio A, Schwed D, Vachani A, Katz SI, Gillespie CT, Cheng G, Sun J, Papasavvas E, Montaner LJ, Heitjan DF, Litzky L, Friedberg J, Culligan M, June CH, Carroll RG, Albelda SM. A trial of intrapleural adenoviral-mediated Interferon-alpha2b gene transfer for malignant pleural mesothelioma. Am J Respir Crit Care Med. 2011 Dec 15;184(12):1395-9. doi: 10.1164/rccm.201103-0554CR. Epub 2011 Jun 3.

Results Reference

derived

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Intrapleural Gene Transfer for Pleural Mesothelioma

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