Gene Therapy for Pleural Malignancies

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Biogen Idec
Information provided by:
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00299962
First received: March 3, 2006
Last updated: September 29, 2010
Last verified: September 2010
  Purpose

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.


Condition Intervention Phase
Pleural Mesothelioma
Metastatic Pleural Effusions
Biological: Adenoviral-mediated Interferon-beta
Biological: SCH 721015
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Clinical Trial of Repeated Dose Intrapleural Adenoviral-Mediated Interferon-beta (BG00001, Ad.hIFN-β for Pleural Malignancies

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • To determine toxicity of two doses of intrapleural BG00001 (Ad.hIFN-β over 8 days, and [ Time Frame: Through Day 85 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To assess systemic and intrapleural cytokine responses as well as cellular and humoral immune responses after repeated BG00001 instillation, [ Time Frame: Through Day 85 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 18
Study Start Date: March 2006
Estimated Study Completion Date: April 2023
Estimated Primary Completion Date: April 2023 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dose level 4 Biological: Adenoviral-mediated Interferon-beta
BG00001 at doses 1.5 x 10e12 and 3 x 10e12 viral particles Days 1 and 8
Other Name: adenoviral-mediated Interferon-beta
Biological: SCH 721015
Comparison of different doses and frequency of investigational agent
Other Names:
  • Adenoviral-mediated Interferon-beta
  • Ad.hIFN-beta
Experimental: Dose level 5 Biological: Adenoviral-mediated Interferon-beta
BG00001 at doses 1.5 x 10e12 and 3 x 10e12 viral particles Days 1 and 8
Other Name: adenoviral-mediated Interferon-beta
Biological: SCH 721015
Comparison of different doses and frequency of investigational agent
Other Names:
  • Adenoviral-mediated Interferon-beta
  • Ad.hIFN-beta
Experimental: Dose Level 1
on Days 1 and 15
Biological: SCH 721015
Comparison of different doses and frequency of investigational agent
Other Names:
  • Adenoviral-mediated Interferon-beta
  • Ad.hIFN-beta
Experimental: Dose Level 2
On Days 1 and 15
Biological: SCH 721015
Comparison of different doses and frequency of investigational agent
Other Names:
  • Adenoviral-mediated Interferon-beta
  • Ad.hIFN-beta
Experimental: Dose Level 3
On Days 1 and 15
Biological: SCH 721015
Comparison of different doses and frequency of investigational agent
Other Names:
  • Adenoviral-mediated Interferon-beta
  • Ad.hIFN-beta

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.

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
  Eligibility

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

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

Locations
United States, Pennsylvania
Hospital of the University of Pennsylvania
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:
No publications provided

Responsible Party: Daniel H. Sterman, M.D., University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00299962     History of Changes
Other Study ID Numbers: 803776, P01CA066726
Study First Received: March 3, 2006
Last Updated: September 29, 2010
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by University of Pennsylvania:
gene therapy
immunotherapy

Additional relevant MeSH terms:
Mesothelioma
Pleural Effusion
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Mesothelial
Pleural Diseases
Respiratory Tract Diseases
Interferon-beta
Interferons
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents

ClinicalTrials.gov processed this record on April 22, 2014