Malignant Pleural Mesothelioma
Conditions
Interventions
Initial dose of 0.4mg of Zoredronic acid will be administered by injection into thoracic cavity. Thereafter, patients will be observed for at least two weeks to evaluate the adverse effects. Transitio
Sponsors
Chiba University Hospital
Chiba Cancer Center Toho University Omori Medical Center Tokyo Women'
s Medical University Yachiyo Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with histologically or cytologically documented malignant pleural mesothelioma Unresectable case(including recurrent case of post-operation) Patients refractory to chemotherapy, or those relapsed after therapies. Patients who reject chemotherapy will be also included. ECOG Performance status 0 to 2 Life expectancy must be longer than 3 month from the entry. Patients who are free of marked failure of major organ function, more over the following criteria must be satisfied in laboratory tests. WBC >=3000/mm3, neutrophil>=1500 /mm3, Hgb>= 8.0 g/dl, Plt >=100.000 /mm3, AST/ALT<= 100 IU/L, T-Bil<=1.5 mg/dl, Cre<=1.5 mg/dl Ccr >=60 ml/min , PaO2>= 60 mmHg or>=90% by pulse oxymetry Informed consent must be obtained
Exclusion criteria
Exclusion criteria: Patient with active multiple primary cancer (synchronous multiple primary cancer and invasive cancer of other organs) Patient with symptomatic brain metastasis requiring any treatments Patient underwent thoracic irradiation therapy or pleurodesis (within a month). Patient with interstitial pneumonia, confirmed by clinical examination or by chest CT scan Patients with history of myocardial infarction (MI) in recent 6 month, or those with any risk of MI recurrence. Patient with other severe medical complications. Patient with history of drug-related allergy to zoredronic acid or other bisphosphonate or those with AEs over Grade 3 in CTCAE. Patient with stomatognathic disease (pulpitis, gingivitis,etc) requiring invasive (surgical) treatment. Patient who received chemotherapy for mesothelioma, or those participated other clinical trial for unapproved drug with in a month. Difficult to participate in the trial because of psychiatric disorder or psychiatric symptoms Pregnant or lactating woman. Ineligible to the trial based on decision of an investigator, such as poor compliance to follow up in the clinical course.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of the incidence of the adverse effect and dose limiting dose(DLT) | — |
Secondary
| Measure | Time frame |
|---|---|
| Anti-tumor effect (Response to the treatment) | — |
Countries
Japan
Contacts
Public ContactYuji Tada
Chiba University Hospital Department of Respirology
Outcome results
None listed