Advanced or metastatic solid tumours that are refractory to standard therapy or for which no standard curative therapy exists MedDRA version: 9.1 Level: LLT Classification code 10049280 Term: Solid tumour
Conditions
Interventions
Product Name: REOLYSIN
Pharmaceutical Form: Solution for injection
Other descriptive name: Reovirus Serotype 3 - Dearing Strain
Concentration type: equal
Concentration number: 1x 10 power 10-
Sponsors
Oncolytics Biotech Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. A diagnosis of histologically or cytologically documented, advanced stage, primary or metastatic solid tumors that are refractory to standard therapy or for which no curative standard therapy exists. 2. Symptomatic disease or disease that is likely to cause symptoms within a short period of time such that palliative radiotherapy is indicated or justified 3. Disease suitable for localised short-course palliative radiotherapy. 4. Local site not previously irradiated 5. Evidence of measurable or evaluable disease. 6. All acute toxic effects of any prior chemotherapy must have resolved to Common Terminology Criteria for Adverse Events (CTCAE, Version 3.0) Grade =1. Surgery (except biopsies) must have occurred at least 28 days prior to study enrolment. 7. Age must be =18 years. 8. Received no chemotherapy, radiotherapy and immunotherapy. Hormonotherapy must have been received > 28 days prior to receiving study drug; patients may continue to receive LHRH analogue therapy for prostate cancer if they have rising PSA, or may continue to receive hormone therapy for breast cancer. 9. ECOG Performance Score of =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Concurrent therapy with any other investigational anticancer agent. 2. Prior radiotherapy to the treatment site. 3. Patients with known brain metastasis(es) must be excluded from this clinical trial because of their poor prognosis and because of frequent development of progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events. 4. Patients on immunosuppressive therapy or with known HIV infection or hepatitis B or C. 5. Pregnant or breast-feeding woman. Female patients of childbearing potential must agree to use effective contraception, must be surgically sterile, or must be postmenopausal. Male patients must agree to use effective contraception or be surgically sterile. Barrier methods are a recommended form of contraception. 6. Clinically significant cardiac disease (New York Heart Association, Class III or IV) including pre-existing arrhythmia, uncontrolled angina pectoris, myocardial infarction 1 year prior to study entry. 7. Investigational therapy, device or biologic within 30 days from screening or while on study. 8. Dementia or altered mental status that would prohibit informed consent. 9. Other severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration or may interfere with the interpretation of study results and, in the judgment of the Principal Investigator, would make the subject inappropriate for this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the antitumor activity of the combination of REOLYSIN and low dose radiotherapy in treated and untreated lesions in patients with advanced cancers including Head, Neck and Esophageal cancer . ;Secondary Objective: a) To evaluate viral replication in treated and untreated lesions. b)To assess the development of immune responses, where possible, to the tumor following the combination treatment. c)To determine the safety and tolerability of intratumoral administration of REOLYSIN to patients with advanced cancer during fractionated radiotherapy ;Primary end point(s): Determination of the antitumor activity of the combination of REOLYSIN and low dose radiotherapy in treated and untreated lesions in patients with advanced cancers including Head, Neck and Esophageal cancer. | — |
Countries
United Kingdom
Outcome results
None listed