Date First Received: March 3, 2006
Last Updated: March 3, 2006
Clinical Trial Phase: Phase 1 Start Date: March 2006
Overall Status: Recruiting
Estimated Enrollment: 15

Intervention(s): Gene Transfer: BG00001 (adenoviral-mediated interferon-beta)

Condition Keyword(s):
• Pleural Mesothelioma
• Metastatic Pleural Effusions

Rationale

This Phase I study will evaluate the safety of two doses of BG00001. 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, on Day 1 and Day 15. BG00001 is given through a catheter in the pleural space.

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.

Study Type: Interventional

Study Design: Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety Study

Outcome Measures for this Clinical Trial

Primary
• To determine the MTD/MED and toxicity of two doses of intrapleural BG00001 (Ad.hIFN-β).

• To analyze Ad.hIFN-β gene transfer with two doses (via pleural fluid ELISA for IFN-β).

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

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

Inclusion Criteria

• pathologically documented malignant pleural effusion from malignant mesothelioma or, metastatic from primary lung, breast, gastrointestinal, genitourinary, melanoma, or sarcoma

• must have evaluable disease

• must have ECOG performance status of 0 or 1

• 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

Exclusion Criteria

• malignant pleural effusions secondary to lymphoma

• rapidly re-accumulating, symptomatic malignant pleural effusions that require immediate mechanical or chemical pleurodesis for palliation

• presence of known untreated brain metastases

• use of concurrent systemic steroids or immunosuppressants

Clinical Trials Locations, Contact Details, and Sponsors

Lead Sponsor: University of Pennsylvania
Hospital of the University of Pennsylvania
Philadelphia Pennsylvania 19104 United States

Overall Clinical Trial Officials and Contacts: Daniel H. Sterman, M.D. Principal Investigator University of Pennsylvania

Overall Contact: Adri Recio, RN 215-573-6760 arecio@mail.med.upenn.edu

Additional Information

Information obtained from ClinicalTrials.gov on April 29, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00299962
Study ID Number: 803776
ClinicalTrials.gov Identifier: NCT00299962

Labels: ClinicalTrial