Gene Therapy for Pleural Malignancies - Full Text View

Purpose

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.

Condition	Intervention	Phase
Pleural Mesothelioma Metastatic Pleural Effusions	Gene Transfer: BG00001 (adenoviral-mediated interferon-beta)	Phase I

MedlinePlus related topics:

Cancer Mesothelioma

Drug Information available for:

Interferon alfa-2b Interferons Interferon beta Interferon-beta

U.S. FDA Resources

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

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

Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:

- 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 Outcome Measures:

- 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.

Estimated Enrollment:	15
Study Start Date:	March 2006
Estimated Study Completion Date:	March 2008

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00299962

Contacts


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

Locations


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

Sponsors and Collaborators

University of Pennsylvania

Biogen Idec

Investigators


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

More Information

website University of Pennsylvania Abramson Cancer Center This link exits the ClinicalTrials.gov site

mesothelioma research foundation This link exits the ClinicalTrials.gov site

Study ID Numbers:	803776, UPCC 03505
First Received:	March 3, 2006
Last Updated:	March 3, 2006
ClinicalTrials.gov Identifier:	NCT00299962
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of Pennsylvania:

gene therapy

immunotherapy

Study placed in the following topic categories:

Pleural Effusion

Respiratory Tract Diseases

Pleural Diseases

Interferons

Interferon-beta

Mesothelioma

Interferon Alfa-2b

Adenoma

Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Anti-Infective Agents

Neoplasms

Neoplasms by Histologic Type

Immunologic Factors

Antineoplastic Agents

Neoplasms, Mesothelial

Therapeutic Uses

Physiological Effects of Drugs

Antiviral Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on November 20, 2008

Sponsors and Collaborators:	University of Pennsylvania Biogen Idec
Information provided by:	University of Pennsylvania
ClinicalTrials.gov Identifier:	NCT00299962