Gene Therapy for Pleural Malignancies
Completed · Phase 1
Conditions studied: Pleural Mesothelioma, Metastatic Pleural Effusions
In brief
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.
Key facts
- Study ID
- NCT00299962
- Run by
- University of Pennsylvania
- People needed
- 17
- Starts
- 2006-03-01
- Expected to finish
- 2009-10-01
- Last updated by the study team
- 2020-03-18
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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
Where it is running
- Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.