A phase II trial to assess the safety, immunological activity of Trovax plus Pemetrexed/ Cisplatin in patients with malignant pleural mesothelioma. - SKOPOS Trial

Velindre NHS Trust0 sites29 target enrollmentMarch 21, 2011

Overview

No summary available.

Registry

who.int

Start Date

March 21, 2011

End Date

May 4, 2016

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Sponsor

Velindre NHS Trust

•Signed and dated written informed consent obtained from the patient in accordance with the local regulations
•Locally advanced or metastatic, histologically or cytologically proven MPM
•Aged 18 years or over
•WHO performance status 0\-1 (Appendix I)
•Life expectancy \> 6months
•Haemoglobin \= 12 g/dl, total white cell count \= 3 x 10^9/L, neutrophil count \> 1\.5 x 10^9/L, lymphocyte count \=1 x 10^9/L, monocyte count \<0\.8 x 10^9/L platelet count \>100 x 10^9/L and \<400 x 10^9/L. Blood transfusion is allowed.
•Adequate renal function: Creatinine \= 50 mL/min as measured by EDTA or 60mL/min as measured by the Cockroft\-Gault formula
•Adequate liver function: ALT, AST and bilirubin \< 2 times the upper limit of normal
•At least four weeks from any previous therapy including surgery, or radiotherapy
•Able to comply with the protocol

•\*Serious infections within the 28 days prior to entry to the trial.
•\*Prior TroVax® treatment
•\*Previous chemotherapy for MPM
•\*Major surgery or radiation therapy completed \= 4 weeks prior to enrolment
•\*Prior radiopharmaceuticals (strontium, samarium) less than 8 weeks prior to enrolment
•\*Participation in any other clinical trial of a licensed or unlicensed drug within the previous 30 days
•\*History of prior malignant disease unless patient has been disease\-free for at least 3 years or the tumour was a non\-melanoma skin cancer or early cervical cancer
•\*Autoimmune disease including systemic Lupus Erythematosis, Grave’s disease, Hashimoto’s thyroiditis, multiple sclerosis, insulin dependent diabetes mellitus or systemic (non\-joint) manifestations of rheumatoid disease
•\*Clinical significant cardiac failure or a measured ejection fraction of \<40%
•\*Other severe acute or chronic medical or psychiatric conditions or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgement of the investigator, would make the patient inappropriate for entry into this study.