Malignant pleural effusion Cancer Secondary malignant neoplasm of respiratory and digestive organs
Conditions
Interventions
An indwelling pleural catheter (PleurX, Denver, Colorado) was placed in the pleural effusion and the pleural space fully drained. After initial complete fluid drainage, 30 ml intra-pleural saline (sal
Sponsors
Oxford University (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged greater than or equal to 18 years, either sex 2. Histocytologically proven malignant pleural effusion 3. A Karnofsky Performance Status of greater than or equal to 60% 4. Life expectancy of more than three months 5. Written informed consent 6. Participants were required to be willing and able to comply with the protocol 7. Participants who were at least 4 weeks from their last chemotherapy cycle
Exclusion criteria
Exclusion criteria: 1. Serious uncontrolled intercurrent infection 2. Proven infection in this episode of pleural effusion 3. Any bleeding diathesis such that chest tube insertion would be hazardous 4. Previous surgical pleurodesis for this pleural effusion 5. Any of the following abnormal laboratory results: 5.1. Haemoglobin less than 8 g/dl (correction by transfusion allowed) 5.2. Neutrophils less than 2.0 x10^9/l 5.3. Platelet count less than 100 x 10^9/l 5.4. Serum creatinine greater than 3 x upper normal limit 5.5. Serum bilirubin greater than 5 x upper normal limit 5.6. Alanine transaminase or aspartate aminotransferase greater than 5 x upper normal limit 6. A known sensitivity to lipoteichoic acid (LTA-T) 7. If female patients were pregnant or lactating; to include all women of childbearing potential unless using a reliable and appropriate contraceptive method was used and a negative pregnancy test was confirmed 8. Any patient with organ allografts, significant cardiac disease, uncontrolled seizures, central nervous system disorders or psychiatric disability 9. Participation in any other investigational drug study within 4 weeks 10. Living too far from the study centre to attend for study follow up
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events (phase I toxicity trial), measured over the entire course of the study (i.e 12 weeks). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To compare the daily production of pleural fluid over days 5 to 10 after administration of intra-pleural LTA-T with that of the previous five days after the administration of intra-pleural saline, compared from week 1 (saline control) to week 2 (LTA-T) 2. To define the time to symptomatic pleural effusion recurrence - 'pleurodesis failure' following LTA-T administration and to estimate by comparison with the published time to recurrence after simple drainage, whether LTA-T reduces the requirement for later pleural effusion drainage, assessed at 1 month 3. To assess whether intra-pleural LTA-T alters the presence of cancer cells in drained pleural fluid and whether it induces a cellular inflammatory pleural fluid response, assessed at 2 weeks and whenever fluid available subsequently 4. To assess whether intra-pleural LTA-T influences the levels of pleural fluid cytokines known to be associated with pleural fluid production, assessed post LTAT administration (3 days) | — |
Countries
United Kingdom
Outcome results
None listed