Overview

This trial is active, not recruiting.

Conditions pleural mesothelioma, metastatic pleural effusions
Treatments adenoviral-mediated interferon-beta, sch 721015
Phase phase 1
Sponsor University of Pennsylvania
Collaborator National Cancer Institute (NCI)
Start date March 2006
End date April 2023
Trial size 18 participants
Trial identifier NCT00299962, 803776, P01CA066726

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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
adenoviral-mediated interferon-beta
BG00001 at doses 1.5 x 10e12 and 3 x 10e12 viral particles Days 1 and 8
sch 721015 Adenoviral-mediated Interferon-beta
Comparison of different doses and frequency of investigational agent
(Experimental)
adenoviral-mediated interferon-beta
BG00001 at doses 1.5 x 10e12 and 3 x 10e12 viral particles Days 1 and 8
sch 721015 Adenoviral-mediated Interferon-beta
Comparison of different doses and frequency of investigational agent
(Experimental)
on Days 1 and 15
sch 721015 Adenoviral-mediated Interferon-beta
Comparison of different doses and frequency of investigational agent
(Experimental)
On Days 1 and 15
sch 721015 Adenoviral-mediated Interferon-beta
Comparison of different doses and frequency of investigational agent
(Experimental)
On Days 1 and 15
sch 721015 Adenoviral-mediated Interferon-beta
Comparison of different doses and frequency of investigational agent

Primary Outcomes

Measure
To determine toxicity of two doses of intrapleural BG00001 (Ad.hIFN-β over 8 days, and
time frame: Through Day 85

Secondary Outcomes

Measure
To assess systemic and intrapleural cytokine responses as well as cellular and humoral immune responses after repeated BG00001 instillation,
time frame: Through Day 85
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

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title A Phase I Clinical Trial of Repeated Dose Intrapleural Adenoviral-Mediated Interferon-beta (BG00001, Ad.hIFN-β for Pleural Malignancies
Principal investigator Daniel H. Sterman, M.D.
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
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by University of Pennsylvania.