Gene Therapy for Pleural Malignancies

Back to results

Primary Purpose

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Adenoviral-mediated Interferon-beta

SCH 721015

About this trial

This is an interventional treatment trial for Pleural Mesothelioma focused on measuring gene therapy, immunotherapy

Eligibility Criteria

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

Inclusion Criteria: must have malignant pleural effusion from mesothelioma or metastatic from primary lung, breast, gastrointestinal, genitourinary, melanoma, or sarcoma must have evaluable disease must have ECOG performance status of 2 must have pleural space involved with tumor accessible for pleural catheter must have FEV1 > 1 liter or 40% of predicted value must have completed radiotherapy and/or treatment with chemotherapy, cytotoxic, or immunologic agents 4 weeks prior to dosing with BG00001 concurrent Tarceva is allowed if patients has been on a stable dose for at least three months and has not had serious adverse events patients on stable dose of hormone may continue use of hormone patients on stable dose of Tarceva for 3 months and without complications may remain on Tarceva Exclusion Criteria: malignant pleural effusions secondary to lymphoma rapidly re-accumulating, symptomatic malignant pleural effusions that require immediate mechanical or chemical pleurodesis for palliation untreated brain metastases use of concurrent systemic steroids or immunosuppressants

Sites / Locations

Hospital of the University of Pennsylvania

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Arm Label

Dose level 4

Dose level 5

Dose Level 1

Dose Level 2

Dose Level 3

Arm Description

on Days 1 and 15

On Days 1 and 15

Outcomes

Primary Outcome Measures

To determine toxicity of two doses of intrapleural BG00001 (Ad.hIFN-β over 8 days, and

Secondary Outcome Measures

To assess systemic and intrapleural cytokine responses as well as cellular and humoral immune responses after repeated BG00001 instillation,

and to assess, in a preliminary way, efficacy via tumor regression, time to progression and survival.

Full Information

NCT ID

NCT00299962

First Posted

March 3, 2006

Last Updated

March 16, 2020

Sponsor

University of Pennsylvania

Collaborators

National Cancer Institute (NCI), Biogen

1. Study Identification

Unique Protocol Identification Number

NCT00299962

Brief Title

Gene Therapy for Pleural Malignancies

Official Title

A Phase I Clinical Trial of Repeated Dose Intrapleural Adenoviral-Mediated Interferon-beta (BG00001, Ad.hIFN-β for Pleural Malignancies

Study Type

Interventional

2. Study Status

Record Verification Date

March 2020

Overall Recruitment Status

Completed

Study Start Date

March 2006 (undefined)

Primary Completion Date

May 2008 (Actual)

Study Completion Date

October 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Pennsylvania

Collaborators

National Cancer Institute (NCI), Biogen

4. Oversight

Data Monitoring Committee

No

5. Study Description

Brief Summary

This Phase I study will evaluate the safety of two doses of BG00001 at different doses and intervals. Eligible subjects will have: malignant pleural mesothelioma, or pleural effusions who have progressed through at least one prior therapy or have refused therapy BG00001 is given twice through a catheter in the pleural space.

Detailed Description

Ad.hIFN-β (BG00001) is a replication-defective recombinant adenoviral vector containing the human interferon-beta (hIFN-β) gene. This Phase I study is designed to evaluate the safety and maximum tolerated dose (MTD) of two doses of intrapleural (IP) Ad.hIFN-β in subjects with pleural malignancies either metastatic or pleural mesothelioma. Five dose levels will be studied: Dose levels 1, 2, and 3 will be given on Days 1 and 15 Dose levels 4 and 5 will be given on Days 1 and 8

6. Conditions and Keywords

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

Pleural Mesothelioma, Metastatic Pleural Effusions

Keywords

gene therapy, immunotherapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

17 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Dose level 4

Arm Type

Experimental

Arm Title

Dose level 5

Arm Type

Experimental

Arm Title

Dose Level 1

Arm Type

Experimental

Arm Description

on Days 1 and 15

Arm Title

Dose Level 2

Arm Type

Experimental

Arm Description

On Days 1 and 15

Arm Title

Dose Level 3

Arm Type

Experimental

Arm Description

On Days 1 and 15

Intervention Type

Biological

Intervention Name(s)

Adenoviral-mediated Interferon-beta

Intervention Description

BG00001 at doses 1.5 x 10e12 and 3 x 10e12 viral particles Days 1 and 8

Intervention Type

Biological

Intervention Name(s)

SCH 721015

Other Intervention Name(s)

Adenoviral-mediated Interferon-beta, Ad.hIFN-beta

Intervention Description

Comparison of different doses and frequency of investigational agent

Primary Outcome Measure Information:

Title

To determine toxicity of two doses of intrapleural BG00001 (Ad.hIFN-β over 8 days, and

Time Frame

Through Day 85

Secondary Outcome Measure Information:

Title

To assess systemic and intrapleural cytokine responses as well as cellular and humoral immune responses after repeated BG00001 instillation,

Time Frame

Through Day 85

Title

and to assess, in a preliminary way, efficacy via tumor regression, time to progression and survival.

Time Frame

15 years or until subject dies, whichever comes first

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: must have malignant pleural effusion from mesothelioma or metastatic from primary lung, breast, gastrointestinal, genitourinary, melanoma, or sarcoma must have evaluable disease must have ECOG performance status of 2 must have pleural space involved with tumor accessible for pleural catheter must have FEV1 > 1 liter or 40% of predicted value must have completed radiotherapy and/or treatment with chemotherapy, cytotoxic, or immunologic agents 4 weeks prior to dosing with BG00001 concurrent Tarceva is allowed if patients has been on a stable dose for at least three months and has not had serious adverse events patients on stable dose of hormone may continue use of hormone patients on stable dose of Tarceva for 3 months and without complications may remain on Tarceva Exclusion Criteria: malignant pleural effusions secondary to lymphoma rapidly re-accumulating, symptomatic malignant pleural effusions that require immediate mechanical or chemical pleurodesis for palliation untreated brain metastases use of concurrent systemic steroids or immunosuppressants

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Daniel H. Sterman, M.D.

Organizational Affiliation

University of Pennsylvania

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hospital of the University of Pennsylvania

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

12. IPD Sharing Statement

Links:

URL

http://www.marf.org

Description

mesothelioma research foundation

Pleural Mesothelioma, Metastatic Pleural Effusions

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial