Clinical trial · Interventional
Intrapleural BG00001 in Treating Patients With Malignant Pleural Mesothelioma or Malignant Pleural Effusions
A Phase I Clinical Trial of Intrapleural Adenoviral-Mediated Interferon-beta (IFN-ß) Gene Transfer for Pleural Malignancies
- 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)
RATIONALE: Using BG00001 to insert the gene for interferon-beta into a person's pleural cavity may improve the body's ability to fight cancer. PURPOSE: Phase I trial to study the effectiveness of intrapleural BG00001 in treating patients who have malignant pleural mesothelioma or malignant pleural effusions.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| recombinant adenovirus-hIFN-beta | Biological | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* One of the following histologically or cytologically confirmed diagnoses:
* Malignant pleural mesothelioma
* Metastatic malignancy to the pleural space
* Originating from 1 of the following sites:
* Lung
* Breast
* Gastrointestinal organs
* Genitourinary organs
* Malignant melanoma
* Failed prior standard therapy comprising chemotherapy, radiotherapy, and/or hormonal therapy
* Measurable or evaluable disease
* Pleural space involved with tumor accessible for pleural catheter insertion
* No malignant pleural effusions secondary to lymphoma or sarcoma
* No rapidly re-accumulating, symptomatic pleural effusions after thoracentesis or pleural catheter insertion that require immediate mechanical or chemical pleurodesis
* No known brain metastases
* Previously treated brain metastases with no evidence of active growth are allowed
* Hormone receptor status:
* Not specified
PATIENT CHARACTERISTICS:
Age
* 18 and over
Sex
* Male or female
Menopausal status
* Not specified
Performance status
* ECOG 0-1
Life expectancy
* Not specified
Hematopoietic
* Granulocyte count at least 2,000/mm\^3
* Platelet count at least 100,000/mm\^3
* Hematocrit at least 30% (transfusion allowed)
Hepatic
* Bilirubin no greater than 1.5 times upper limit of normal (ULN)
* ALT and AST no greater than 1.5 times ULN
* Alkaline phosphatase no greater than 1.5 times ULN
* PT and PTT no greater than 1.5 times normal
* No end-stage liver disease
* No chronic active hepatitis B (hepatitis B surface antigen negative)
Renal
* Creatinine no greater than 2.0 mg/dL
* No end-stage renal disease
Cardiovascular
* No unstable angina
Pulmonary
* FEV\_1 greater than 50% of predicted (post-pleural drainage)
* No severe oxygen-dependent chronic obstructive pulmonary disease
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* HIV negative
* No documented immunodeficiency
* No other malignancy within the past 5 years except nonmelanoma skin cancer or successfully treated localized malignancy of the bladder or prostate gland with no evidence of active disease
* No other life-threatening illness
* No known hypersensitivity to any component of study treatment
PRIOR CONCURRENT THERAPY:
Biologic therapy
* More than 4 weeks since prior biologic therapy
* No prior bone marrow transplantation, including stem cells
* No immunological drugs during and for at least 2 months after study therapy
Chemotherapy
* See Disease Characteristics
* No chemotherapy during and for at least 2 months after study therapy
Endocrine therapy
* See Disease Characteristics
* Concurrent hormonal therapy allowed if maintained at dose received prior to study entry
* No concurrent steroids
Radiotherapy
* See Disease Characteristics
* More than 4 weeks since prior radiotherapy
* No radiotherapy during and for at least 2 months after study therapy
Surgery
* At least 2 weeks since prior surgery
Other
* More than 4 weeks since prior cytotoxic agents
* No concurrent immunosuppressives or medication that can directly or indirectly suppress the immune system
* No other concurrent experimental therapies for pleural cancerReferences
Publications (1)
- RESULTSterman DH, Recio A, Haas AR, Vachani A, Katz SI, Gillespie CT, Cheng G, Sun J, Moon E, Pereira L, Wang X, Heitjan DF, Litzky L, June CH, Vonderheide RH, Carroll RG, Albelda SM. A phase I trial of repeated intrapleural adenoviral-mediated interferon-beta gene transfer for mesothelioma and metastatic pleural effusions. Mol Ther. 2010 Apr;18(4):852-60. doi: 10.1038/mt.2009.309. Epub 2010 Jan 12. PMID 20068553