Gene Therapy for Pleural Malignancies

March 16, 2020 updated by: University of Pennsylvania

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Hospital of the University of Pennsylvania

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Dose level 4
Biological: Adenoviral-mediated Interferon-beta
BG00001 at doses 1.5 x 10e12 and 3 x 10e12 viral particles Days 1 and 8
Biological: SCH 721015
Comparison of different doses and frequency of investigational agent
Other Names:
  • Adenoviral-mediated Interferon-beta
  • Ad.hIFN-beta
EXPERIMENTAL: Dose level 5
Biological: Adenoviral-mediated Interferon-beta
BG00001 at doses 1.5 x 10e12 and 3 x 10e12 viral particles Days 1 and 8
Biological: SCH 721015
Comparison of different doses and frequency of investigational agent
Other Names:
  • Adenoviral-mediated Interferon-beta
  • Ad.hIFN-beta
EXPERIMENTAL: Dose Level 1
on Days 1 and 15
Biological: SCH 721015
Comparison of different doses and frequency of investigational agent
Other Names:
  • Adenoviral-mediated Interferon-beta
  • Ad.hIFN-beta
EXPERIMENTAL: Dose Level 2
On Days 1 and 15
Biological: SCH 721015
Comparison of different doses and frequency of investigational agent
Other Names:
  • Adenoviral-mediated Interferon-beta
  • Ad.hIFN-beta
EXPERIMENTAL: Dose Level 3
On Days 1 and 15
Biological: SCH 721015
Comparison of different doses and frequency of investigational agent
Other Names:
  • Adenoviral-mediated Interferon-beta
  • Ad.hIFN-beta

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To determine toxicity of two doses of intrapleural BG00001 (Ad.hIFN-β over 8 days, and
Time Frame: Through Day 85
Through Day 85

Secondary Outcome Measures

Outcome Measure
Time Frame
To assess systemic and intrapleural cytokine responses as well as cellular and humoral immune responses after repeated BG00001 instillation,
Time Frame: Through Day 85
Through Day 85
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
15 years or until subject dies, whichever comes first

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pennsylvania

Collaborators

National Cancer Institute (NCI)
Biogen

Investigators

  • Principal Investigator: Daniel H. Sterman, M.D., University of Pennsylvania

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2006

Primary Completion (ACTUAL)

May 1, 2008

Study Completion (ACTUAL)

October 1, 2009

Study Registration Dates

First Submitted

March 3, 2006

First Submitted That Met QC Criteria

March 3, 2006

First Posted (ESTIMATE)

March 7, 2006

Study Record Updates

Last Update Posted (ACTUAL)

March 18, 2020

Last Update Submitted That Met QC Criteria

March 16, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 803776
  • P01CA066726 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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