Vascular Targeted Photodynamic Therapy T1a Renal Tumours (KCM201)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by University of Oxford
Sponsor:
Collaborator:
Steba Biotech S.A.
Information provided by (Responsible Party):
University of Oxford
ClinicalTrials.gov Identifier:
NCT01573156
First received: March 22, 2012
Last updated: July 1, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention Phase
Renal Cancer
Drug: Light activated WST11
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Vascular Targeted Photodynamic Therapy With WST11 for T1a Renal Tumours. PHASE IIa Histological Follow up Trial

Resource links provided by NLM:


Further study details as provided by University of Oxford:

Primary Outcome Measures:
  • Volume of tumour necrosis on final histology expressed as a percentage of pre-treatment tumour volume [ Time Frame: 2-4 weeks post VTP therapy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 [ Time Frame: 12 days post VTP therapy ] [ Designated as safety issue: No ]
  • Adverse events according to Common Toxicity Criteria (CTCAE) [ Time Frame: Up to 12 months post VTP ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 12
Study Start Date: May 2013
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: VTP treatment to small renal mass Drug: Light activated WST11
WST11-mediated VTP will consist of the combination of a single IV administration of WST11 at doses of 2 mg/kg, or 4mg/kg using 753 nm laser light at a fixed power (150 mW/cm) and energy (200 J/cm) delivered through percutaneous optical fibres. The fibres are introduced into transparent needles that are positioned in the areas of interest under CT image guidance. After a minimum of 3 patients at each drug dosage (2 & 4 mg/kg) has been treated with a light energy of 200 J/cm, the general and local safety will be assessed. The safety results of the first 3 patients treated in each drug dose/number of fibres combination will be reviewed by the investigators prior to escalation to a higher drug dose/number of fibres combination.
Other Name: Tookad Soluble

  Eligibility

Ages Eligible for Study:   60 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01573156

Contacts
Contact: Tom Leslie, MD D.Phil (Oxon) FRCS Urol 00441865763100 tom.leslie@nds.ox.ac.uk

Locations
United Kingdom
Churchill Hospital Recruiting
Oxford, United Kingdom, OX44 9LS
Contact: Tom Leslie, MD PhD       tom.leslie@nds.ox.ac.uk   
Sponsors and Collaborators
University of Oxford
Steba Biotech S.A.
Investigators
Principal Investigator: Mark Sullivan, MD FRCS Urol Churchill Hospital, Oxford, UK
  More Information

No publications provided

Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT01573156     History of Changes
Other Study ID Numbers: CLIN1102 KCM201, 2011-003311-27
Study First Received: March 22, 2012
Last Updated: July 1, 2013
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by University of Oxford:
renal cancer
photodynamic therapy
wst 11

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Kidney Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on September 18, 2014