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

Phase 1

• Conditions: The study is for patients with malignant mesothelioma of the lung lining(called pleura).; MedDRA version: 13.1 Level: PT Classification code 10035603 Term: Pleural mesothelioma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

• Registration Number: EUCTR2010-023230-22-GB
• Lead Sponsor: Velindre NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-03-21
• Study Completion: 2016-05-04
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 29

Inclusion Criteria

• 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
• Women must be either post-menopausal, or rendered surgically sterile or, if of child-bearing potential, must have a negative pregnancy test prior to trial entry. Two reliable forms of contraception (oral contraception and a barrier method) must be used by all participants while they are being treated with the TroVax® vaccine. Females must continue to use this level of contraception for 3 months following the last trial treatment, and male patients must continue for 1 month.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

*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.
*Chronic oral corticosteroid use unless prescribed as replacement therapy in the case of adrenal insufficiency, or other immunosuppressive agents. Dexamethasone is allowed as part of trial treatment.
*Cerebral metastases
*History of allergic response to previous vaccine vaccinations
*Known allergy to egg proteins
*Known to test positive for HIV or hepatitis B or C
*Pregnancy or lactation
*Prior history of organ transplantation

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified