ight activated drug treatment for small kidney tumours
- Conditions
- T1a renal cancerMedDRA version: 15.0 Level: PT Classification code 10038391 Term: Renal cancer stage I System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2011-003311-27-GB
- Lead Sponsor
- niversity of Oxford
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 5
• Participant is willing and able to give informed consent for participation in the study. • Male or post-menopausal female, aged 18 years or above. • Lesions suspicious for renal cell carcinoma on triple phase CT that are < 4cm in maximum diameter and suitable for surgical resection • Participant must be in sufficiently good health to be suitable for general anaesthesia for both VTP treatment and subsequent surgical resection of tumour • Subjects must have = 1 evaluable tumours which can be visualised on diagnostic ultrasound. If more than one tumour exists, an index tumour will be nominated and treated (uncommon) • Previous chemotherapy and / or biological therapy for cancer are permitted, but the subject should have recovered fully from the effects of these and any prior surgery (minimum of 28 days). • Patients should not have received radiotherapy to the target area within the preceding 12 months. • Subject has clinically acceptable haematological, electrolyte and hepatic function as demonstrated by serum laboratory values within 14 days prior of VTP treatment: ? Absolute neutrophil count (ANC) = 1500mm-3 ? Platelet count = 100,000mm-3 ? Haemoglobin = 10gdl-1 ? Prothrombin time (PT) = 1.5 * Upper Limit of Normal (ULN) ? Activated partial thomboplastin time (APPT) = 1.5 * ULN ? Total bilirubin < 2.5 * ULN ? Aspartate aminotransferase (AST) < 3 * ULN ? Alkaline phosphatase (ALP) < 2 * ULN; unless arising from bone • Participant has a clinically acceptable ECG • Able (in the Investigators opinion) and willing to comply with all study requirements. • Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the study
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 4
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 8
• Non menopausal women • Significant hepatic impairment. • Significant renal impairment as to mean surgical resection is unsuitable • Clinical or radiological evidence of metastatic disease • Subjects with tumours lying adjacent to vital structures such that VTP treatment would risk damage to these structures • Subjects currently taking immunosuppressive medication • Patients whose medical conditions need the following medication which have potential photosensitising effects (tetracyclines, sulphonamides, phenothiazines, sulfonylurea hypoglycaemic agents, thiazide diuretics, amiodarone and griseofulvin) if these treatments cannot be stopped or replaced by other treatments without photosensitizing properties • Patients who have an absolute need for anticoagulant drugs or antiplatelet drugs (e.g., warfarin, aspirin) which cannot be withdrawn during the 10 days prior to the VTP procedure. • Scheduled elective surgery or other procedures requiring general anaesthesia during the study. • Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant’s ability to participate in the study. • Participants involved in the treatment phase of a clinical trial (observational or follow-up studies will be allowed) • An American Society of Anaesthesiologists (ASA) score of = 3 • A World Health Organisation (WHO) performance status of =2
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate efficacy of VTP treatment as assessed by histology in T1a Renal Tumours;Secondary Objective: To evaluate technical success of VTP treatment as assessed by radiology follow-up in T1a Renal Tumours (radiological evidence of tumour destruction at day 12 following VTP treatment) To evaluate safety and toxicity of VTP treatment for T1a Renal Tumours To improve treatments parameters and patient selection for future treatments for T1a Renal Tumours;Primary end point(s): Volume of tumour necrosis on final histology expressed as a percentage of pre-treatment tumour volume;Timepoint(s) of evaluation of this end point: Following the partial nephrectomy, which will be 2-4 weeks following the VTP treatment
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Complete destruction of targeted tumour on day 12 MRI imaging AEs / toxicity following VTP treatment Oncological outcome (assessed radiologically) following VTP & surgery up to 1 year post treatment;Timepoint(s) of evaluation of this end point: Day 12 MRI Up to 1 year following surgery