Gene Therapy for Pleural Malignancies
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.
Checked against the public recordLast updated Mar 18, 2020 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1
- Sponsor
- University of Pennsylvania
- Interventions being studied
- Biological: Adenoviral-mediated Interferon-beta; Biological: SCH 721015
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Hospital of the University of PennsylvaniaPhiladelphia, Pennsylvania
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Mar 18, 2020. Always confirm current availability with the study team.