Gene Therapy for Pleural Malignancies

Pleural Mesothelioma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00299962
• Other study ID #: 803776
• Secondary ID: P01CA066726
• Status: Completed
• Phase: Phase 1
• Start date: March 2006
• Est. completion date: October 2009

Study information

• Verified date: March 2020
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: October 2009
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mesothelioma
• Metastatic Pleural Effusions
• Pleural Effusion
• Pleural Mesothelioma

Intervention

Biological:
• Adenoviral-mediated Interferon-beta
BG00001 at doses 1.5 x 10e12 and 3 x 10e12 viral particles Days 1 and 8
• SCH 721015
Comparison of different doses and frequency of investigational agent

Locations

Country	Name	City	State
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
University of Pennsylvania	Biogen, National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine toxicity of two doses of intrapleural BG00001 (Ad.hIFN-ß over 8 days, and		Through Day 85
Secondary	To assess systemic and intrapleural cytokine responses as well as cellular and humoral immune responses after repeated BG00001 instillation,		Through Day 85
Secondary	and to assess, in a preliminary way, efficacy via tumor regression, time to progression and survival.		15 years or until subject dies, whichever comes first

External Links

•   mesothelioma research foundation