Know Cancer

forgot password

Vascular Targeted Photodynamic Therapy With WST11 for T1a Renal Tumours. PHASE IIa Histological Follow up Trial

Phase 1/Phase 2
18 Years
90 Years
Not Enrolling
Renal Cancer

Thank you

Trial Information

Vascular Targeted Photodynamic Therapy With WST11 for T1a Renal Tumours. PHASE IIa Histological Follow up Trial

Inclusion Criteria:

- Participant is willing and able to give informed consent for participation in the

- 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

- Participants has a clinically acceptable ECG

- Able (in the Investigators opinion) and willing to comply with all study

- 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
photosensitising 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

- 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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Volume of tumour necrosis on final histology expressed as a percentage of pre-treatment tumour volume

Outcome Time Frame:

2-4 weeks post VTP therapy

Safety Issue:


Principal Investigator

Mark Sullivan, MD FRCS Urol

Investigator Role:

Principal Investigator

Investigator Affiliation:

Churchill Hospital, Oxford, UK


United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study ID:

CLIN1102 KCM201



Start Date:

May 2012

Completion Date:

October 2013

Related Keywords:

  • Renal Cancer
  • renal cancer
  • photodynamic therapy
  • wst 11
  • Carcinoma, Renal Cell
  • Kidney Neoplasms