Gene Therapy for Pleural Malignancies - Full Text View

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

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 beta Interferon-beta Interferons

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

Additional 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

No publications provided

Study ID Numbers:	803776, UPCC 03505
Study First Received:	March 3, 2006
Last Updated:	March 3, 2006
ClinicalTrials.gov Identifier:	NCT00299962 History of Changes
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
Immunologic Factors
Respiratory Tract Diseases
Pleural Diseases
Interferons

Interferon-beta
Mesothelioma
Antiviral Agents
Adenoma
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Anti-Infective Agents
Neoplasms by Histologic Type
Immunologic Factors
Antineoplastic Agents
Neoplasms, Mesothelial
Pleural Diseases
Physiological Effects of Drugs
Interferons
Interferon-beta

Antiviral Agents
Pharmacologic Actions
Pleural Effusion
Neoplasms
Respiratory Tract Diseases
Therapeutic Uses
Mesothelioma
Adenoma
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on May 06, 2009