Safety and Efficacy of Oshadi D and Oshadi R for Malignant Mesothelioma Treatment

Inclusion Criteria:

• Histologically or cytologically proven diagnosis of malignant mesothelioma
• Man or woman 21 years and above
• Adequate performance status (ECOG 0, 1, or 2)

• Patient must have adequate organ function as the following:

  • Absolute neutrophils counts (ANS) > 2500/μL.
  • Platelets > 150,000/μL.
  • Hemoglobin > 10 g/dL.
  • Total Bilirubin < 1.5 Upper Normal Limit (UNL).
  • Alanine aminotransferase (ALT), AST and alkaline phosphatase must be < 1.5 times of the upper limit of normal.
  • LDH < 500 int. unit/L
  • Estimated GFR > 45 ml/min.
• Written informed consent
• Females of childbearing potential and males must be willing to use an effective method of contraception (hormonal or barrier method of birth control; abstinence) from the time consent is signed until 6 weeks after treatment discontinuation.
• Females of childbearing potential must have a negative pregnancy test within 7 days prior to being registered for protocol therapy.

Exclusion Criteria:

• Evidence of liver metastasis
• Any bone involvement
• Prior radiotherapy, cytotoxic or biologic systemic treatment
• Any history of Asthma or COPD that needs systemic therapy with steroids for more than 2 weeks during the last 2 years.
• Treatment with systemic steroids for more then 1 month during the last year.
• Active smokers that are unable to quite smoking
• Any treatment with investigational agent within 30 days prior to registration for protocol therapy.
• Cerebrovascular accident, transient ischemic attack or myocardial infarction within 6 months prior to registration for protocol therapy.
• Evidence of pulmonary embolism within 6 months prior to registration for protocol therapy.
• Any history of solid or hematologic malignancies.
• Patient with positive HIV serology at screening.
• Female patient who are breastfeeding or have a positive pregnancy test at screening or at any time during the study.
• Uncontrolled hypertension (> 150/100 mm Hg despite optimal medical therapy).
• Evidence of ongoing cardiac dysrhythmias of NCI CTCAE Version 3.0 grade 2.
• Patients in whom radiation or surgery is indicated
• Significant swallowing disorders.
• Small bowel surgery.
• Suspicion of absorption disruption as a result of abdominal radiation
• Pre-existing malabsorption syndrome, irritable bowel syndrome or other clinical situation which could affect oral absorption.
• Evidence of concurrent (< 5 years) second malignancy
• Mental disorders.
• Inability to give written informed consent.