Clinical trial NCT01573156: Vascular Targeted Photodynamic Therapy T1a Renal Tumours
Official title: Vascular Targeted Photodynamic Therapy With WST11 for T1a Renal Tumours. PHASE IIa Histological Follow up Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Renal Cancer
Keywords: renal cancer
photodynamic therapy
wst 11
Lead sponsor: University of Oxford
Sponsor class: OTHER
Collaborators: name: Steba Biotech S.A.
First posted: 2012-04-06
Enrollment: 5
Sex: ALL
Minimum age (years): 60
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Vascular Targeted Photodynamic therapy (VTP) with the Vascular Occluding Agent (VOA) WST11, may offer an alternative, providing tumour destruction via a minimally invasive approach. In this investigation, the investigators plan to use the WST11 VTP procedure to treat a predetermined small renal tumour targets. Patients will be given a general anaesthetic, to ensure immobility, and prevent discomfort during treatment sessions. Treated patients will then undergo surgical resection of their tumours, and the accuracy and reliability of tissue death with VTP will be assessed histologically. The aim of this proof of concept study is to demonstrate whether this modality has potential for a clinical role in the treatment of oncological kidney disease, either as an alternative to surgery, or where surgery is not feasible.


Eligibility criteria: Inclusion Criteria:

* Participant is willing and able to give informed consent for participation in the study.
* Male or post-menopausal female, aged 60 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 visualized 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 thromboplastin time (APPT) ≤ 1.5 \* ULN
* Total bilirubin \< 2.5 \* ULN
* Aspartate aminotransferase (AST) \< 3 \* ULN
* Alkaline phosphatase (ALP) \< 2 \* ULN; unless arising from bone
* Participants 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.

Exclusion Criteria:

The participant may not enter the study if ANY of the following apply:

* 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 photosensitizing effects (tetracyclines, sulphonamides, phenothiazines, sulfonylurea hypoglycaemic agents, thiazide diuretics, griseofulvin and amiodarone (see appendix G)) 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 Organization (WHO) performance status of ≥2

Primary outcomes:
measure: Volume of tumour necrosis on final histology expressed as a percentage of pre-treatment tumour volume
timeFrame: 2-4 weeks post VTP therapy
Secondary outcomes:
measure: Radiological evidence of tissue destruction at day 12 (technical success) based on the volume of tumour ablation on day 12 MRI imaging expressed as a percentage of pre-treatment tumour volume
timeFrame: 12 days post VTP therapy
measure: Adverse events according to Common Toxicity Criteria (CTCAE)
timeFrame: Up to 12 months post VTP
Other outcomes:
Locations:
city: Oxford
country: United Kingdom
facility: Churchill Hospital
Study officials:
affiliation: Churchill Hospital, Oxford, UK
name: Mark Sullivan, MD FRCS Urol
role: PRINCIPAL_INVESTIGATOR
References: