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Renal CancerPhase 1/2KCM201NCT01573156

Vascular Targeted Photodynamic Therapy T1a Renal Tumours

A Phase 1/2 study testing Light activated WST11 in people with Renal Cancer, run by University of Oxford at 1 site in United Kingdom.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 60 to 90 years
Conditions the study is for
Renal Cancer
What is being tested?
Light activated WST11
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5 participants
Where
1 siteUnited Kingdom
Study dates
May 2013to Jun 2015
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).
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  • 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.

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • Churchill Hospital

    Oxford, OX44 9LS

Other trials in United Kingdom

About this study

Official title: 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.

Conditions
Renal Cancer
Being tested
Light activated WST11
Keywords
renal cancer, photodynamic therapy, wst 11
Medical subject headings
Kidney Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Light activated WST11Drug

    Also called Tookad Soluble

    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.

Study groups in NCT01573156
Study groupRoleWhat they receive
VTP treatment to small renal massExperimentalNot described
Receives: Drug: Light activated WST11

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 2-4 weeks post VTP therapy

Secondary outcomes (2)

  1. 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

    Measured: 12 days post VTP therapy

  2. Adverse events according to Common Toxicity Criteria (CTCAE)

    Measured: Up to 12 months post VTP

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Apr 2012 (estimated)
  2. Study startMay 2013
  3. Primary completionMay 2014
  4. Study completionJun 2015

Why it stopped: Concerns about post VTP MRI results being conclusive

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
5 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01573156
Sponsor's protocol ID
CLIN1102 KCM201
Other IDs
2011-003311-27
Acronym
KCM201
Status last verified
Jan 2018
First submitted
22 Mar 2012
Last updated
10 Jan 2018
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Light activated WST11 in people with Renal Cancer, run by University of Oxford at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 10 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Concerns about post VTP MRI results being conclusive). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01573156.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2018.

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