A Multi-Centre Single-Arm Phase II Study To Evaluate The Biological Effects Of Intratumoral Administration of Wild-Type Reovirus (REOLYSIN®) in Combination with Low Dose Radiation in Patients With Advanced Cancers Including Head, Neck and Esophageal Cancer.
- Conditions
- Advanced or metastatic solid tumours that are refractory to standard therapy or for which no standard curative therapy existsMedDRA version: 9.1Level: LLTClassification code 10049280Term: Solid tumour
- Registration Number
- EUCTR2006-002190-49-GB
- Lead Sponsor
- Oncolytics Biotech Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 40
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 <2.
10. Life expectancy of at least 3 months.
11. Required baseline laboratory data include:
•Absolute neutrophil count (ANC) = 1.5 x 109 [SI units 109/L]
•Platelets = 100 x109 [SI units 109/L]
•Haemoglobin = 9.0 g/dL [SI units gm/L]
•Serum creatinine = 1.5 x upper limit of normal (ULN)
•Bilirubin = 1.5 x ULN
•AST/ALT = 2.5 x ULN
•PT/PTT = 1.5 x upper limit of normal
•Negative pregnancy test for females of childbearing potential
12.Signed informed consent indicating that the patient is aware of the neoplastic nature of the disease and has been informed of the procedures to be followed, the experimental nature of the therapy, alternatives, potential benefits, side effects, risks, and discomforts.
13.Willing and able to comply with scheduled visits, treatment plan, and laboratory tests.
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 .<br><br>;Secondary Objective: a) To evaluate viral replication in treated and untreated lesions. <br>b)To assess the development of immune responses, where possible, to the tumor following the combination treatment.<br>c)To determine the safety and tolerability of intratumoral administration of REOLYSIN to patients with advanced cancer during fractionated radiotherapy<br>;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.
- Secondary Outcome Measures
Name Time Method