From the blog

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

Published: July 17, 2012

Primary Outcome Measures:

  • Adverse events and serious adverse events occurence [ Time Frame: One month following treatment initiation ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

  • overall survival time [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Eligibility Criteria

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.
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