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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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on November 20, 2014