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 (aspartate aminotransferase)and alkaline phosphatase must be \< 1.5 times of the upper limit of normal.
  * LDH (lactate dehydrogenase) \< 500 int. unit/L
  * Estimated GFR (glomerular filtration rate) \> 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 (chronic obstructive pulmonary disease) 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 (Common Toxicity Criteria for Adverse Effects) 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.