Gene Therapy for Pleural Malignancies

University of Pennsylvania17 enrolled

Overview

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.

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

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pleural Mesothelioma Metastatic Pleural Effusions

Interventions

Adenoviral-mediated Interferon-betaBIOLOGICAL

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

SCH 721015BIOLOGICAL

Comparison of different doses and frequency of investigational agent

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Outcomes

Primary Outcomes

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

Time frame: Through Day 85

Secondary Outcomes

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

Time frame: 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

Data from ClinicalTrials.gov

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