Clinical trial NCT01627795: Safety and Efficacy of Oshadi D and Oshadi R for Malignant Mesothelioma Treatment
Official title: A Single-center, Open Label Study for Evaluation of the Safety and Efficacy of Oshadi D and Oshadi R for Malignant Mesothelioma Treatment - A Phase IIa Study
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE1
PHASE2
Conditions: Mesothelioma
Keywords: Malignant Mesothelioma
Cancer
Anti cancer agents
Lead sponsor: Oshadi Drug Administration
Sponsor class: INDUSTRY
First posted: 2012-06-26
Enrollment: 17
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Malignant mesothelioma is a rare neoplasm that arises most commonly from the mesothelial surfaces of the pleural cavity, occasionally from the peritoneal surface, and rarely from the tunica vaginalis or pericardium. It has an extremely poor prognosis with a median survival of 4 to 13 months for untreated patients 1 and 6 to 18 months for treated patients, regardless of the therapeutic approach.

The anticancer activity of Oshadi D and Oshadi R treatment was tested in preclinical studies and in phase I clinical study. Four metastatic mesothelioma patients are treated for 5 to 12 months. The Oshadi D and Oshadi R combination treatment was generally well-tolerated with no dose-limiting toxicities observed.


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 (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.

Primary outcomes:
measure: Adverse events and serious adverse events occurence
timeFrame: One month following treatment initiation
Secondary outcomes:
measure: overall survival time
timeFrame: 12 months
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Center
Study officials:
affiliation: Hadassah Medical Organization
name: Hovav Nehushtan, Prof.
role: PRINCIPAL_INVESTIGATOR
References: