NCT00299962

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Mar 2006

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2006

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

March 3, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 7, 2006

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
Last Updated

March 18, 2020

Status Verified

March 1, 2020

Enrollment Period

2.2 years

First QC Date

March 3, 2006

Last Update Submit

March 16, 2020

Conditions

Pleural MesotheliomaMetastatic Pleural Effusions

Keywords

gene therapyimmunotherapy

Outcome Measures

Primary Outcomes (1)

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

    Through Day 85

Secondary Outcomes (2)

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

    Through Day 85

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

    15 years or until subject dies, whichever comes first

Study Arms (5)

Dose level 4

EXPERIMENTAL
Biological: Adenoviral-mediated Interferon-betaBiological: SCH 721015

Dose level 5

EXPERIMENTAL
Biological: Adenoviral-mediated Interferon-betaBiological: SCH 721015

Dose Level 1

EXPERIMENTAL

on Days 1 and 15

Biological: SCH 721015

Dose Level 2

EXPERIMENTAL

On Days 1 and 15

Biological: SCH 721015

Dose Level 3

EXPERIMENTAL

On Days 1 and 15

Biological: SCH 721015

Interventions

Adenoviral-mediated Interferon-betaBIOLOGICAL

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

Dose level 4Dose level 5
SCH 721015BIOLOGICAL

Comparison of different doses and frequency of investigational agent

Also known as: Adenoviral-mediated Interferon-beta, Ad.hIFN-beta
Dose Level 1Dose Level 2Dose Level 3Dose level 4Dose level 5

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Links

MeSH Terms

Conditions

Mesothelioma, MalignantPleural Effusion

Condition Hierarchy (Ancestors)

MesotheliomaAdenomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, MesothelialLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SitePleural NeoplasmsLung DiseasesRespiratory Tract DiseasesPleural Diseases

Study Officials

  • Daniel H. Sterman, M.D.

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 3, 2006

First Posted

March 7, 2006

Study Start

March 1, 2006

Primary Completion

May 1, 2008

Study Completion

October 1, 2009

Last Updated

March 18, 2020

Record last verified: 2020-03

Locations

US(1)