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Vascular Targeted Photodynamic Therapy T1a Renal Tumours (KCM201)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2013 by University of Oxford.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01573156
First Posted: April 6, 2012
Last Update Posted: July 2, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Steba Biotech S.A.
Information provided by (Responsible Party):
University of Oxford
March 22, 2012
April 6, 2012
July 2, 2013
May 2013
May 2014   (Final data collection date for primary outcome measure)
Volume of tumour necrosis on final histology expressed as a percentage of pre-treatment tumour volume [ Time Frame: 2-4 weeks post VTP therapy ]
Same as current
Complete list of historical versions of study NCT01573156 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Adverse events according to Common Toxicity Criteria (CTCAE) [ Time Frame: Up to 12 months post VTP ]
Same as current
Not Provided
Not Provided
 
Vascular Targeted Photodynamic Therapy T1a Renal Tumours
Vascular Targeted Photodynamic Therapy With WST11 for T1a Renal Tumours. PHASE IIa Histological Follow up Trial
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.
Not Provided
Interventional
Phase 1
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Renal Cancer
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
Experimental: VTP treatment to small renal mass
Intervention: Drug: Light activated WST11
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
12
June 2015
May 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
60 Years to 90 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
 
NCT01573156
CLIN1102 KCM201
2011-003311-27 ( EudraCT Number )
Yes
Not Provided
Not Provided
University of Oxford
University of Oxford
Steba Biotech S.A.
Principal Investigator: Mark Sullivan, MD FRCS Urol Churchill Hospital, Oxford, UK
University of Oxford
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP