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Gene Therapy for Pleural Malignancies

NCT00299962 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2020-03-18

No results posted yet for this study

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.

Conditions

  • Pleural Mesothelioma
  • Metastatic Pleural Effusions

Interventions

BIOLOGICAL

Adenoviral-mediated Interferon-beta

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

BIOLOGICAL

SCH 721015

Comparison of different doses and frequency of investigational agent

Sponsors & Collaborators

Principal Investigators

  • Daniel H. Sterman, M.D. · University of Pennsylvania

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-03-31
Primary Completion
2008-05-31
Completion
2009-10-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00299962 on ClinicalTrials.gov