Clinical trial · Interventional
Gene Therapy for Pleural Malignancies
A Phase I Clinical Trial of Repeated Dose Intrapleural Adenoviral-Mediated Interferon-beta (BG00001, Ad.hIFN-β for Pleural Malignancies
NCT00299962CI-TRIAL-00044077completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Pleural Effusions | — | UNRESOLVED | — |
| Pleural Mesothelioma | Pleural Mesothelial Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Adenoviral-mediated Interferon-beta | Biological | — | UNRESOLVED |
| SCH 721015 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (5)
- type
- EXPERIMENTAL
- label
- Dose level 4
- interventionNames
- Biological: Adenoviral-mediated Interferon-beta
- Biological: SCH 721015
- type
- EXPERIMENTAL
- label
- Dose level 5
- interventionNames
- Biological: Adenoviral-mediated Interferon-beta
- Biological: SCH 721015
- type
- EXPERIMENTAL
- label
- Dose Level 1
- description
- on Days 1 and 15
- interventionNames
- Biological: SCH 721015
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.