Primary soft tissue sarcoma in the upper and lower limbs of adults. MedDRA version: 13 Level: LLT Classification code 10061271 Term: Malignant soft tissue neoplasm MedDRA version: 13 Level: LLT Classification code 10039491 Term: Sarcoma
Conditions
Interventions
Trade Name: Verteporfin (Visudyne)
Product Name: Verteporfin (Visudyne)
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: Verteporfin
CAS Number: 129497-78-5
Sponsors
Research & Development Department
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Primary malignant, biopsy proven soft tissue sarcoma of the upper or lower limbs. Adults (over 18 years of age). Patients able to give informed written consent. Patients undergoing limb-sparing surgery. Unifocal tumour. Women of child-bearing potential with negative pregnancy test prior to study entry AND be using an adequate contraceptive method, which must be continued for 1 week following PDT. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Previous treatment for the tumour (either surgery or radiotherapy) or tumour recurrence. Skin photosensitivity (including porphyrea). Patients with known sensitivity to photosensitizers. Metastatic disease. Patients with severe cardiovascular disease. Pregnancy and lactation. Evidence of severe or uncontrolled systemic disease such as hepatic impairment or laboratory findings that makes it undesirable for the patient to participate in the trial. Any psychiatric disorder making reliable informed consent impossible. Taking part in any other trial of an experimental medicine.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The trial aims to investigate the safety and efficacy of verteporfin photodynamic therapy in patients with soft tissue sarcomas in the arms or legs. The primary endpoint is the diameter of necrosis of tumour achieved around a single fibre for a given light energy. We aim to establish the minimum light dose, in the range 20J to 50J, required to induce an area of necrosis with a diameter of at least 12mm. Once we have established the light dose that achieves this in 3 consecutive patients, we will study a further 7 patients with the same light dose.;Secondary Objective: What effect does photodynamic therapy have on the histopathology of the tumour and normal surrounding tissues? To look at the effect of Photodynamic Therapy on the tumour and normal soft tissues and study if necrosis extends to normal tissue. What effect does photodynamic therapy have on the MRI appearance of the sarcoma? To radiologically assess the response of the Photodynamic Therapy on sarcomas we will use pre and post PDT MRI and compare with final histology. We will measure the diameter of necrosis on MRI scan which will be compared with the histological measurement.;Primary end point(s): The primary outcome is the maximum diameter of the area of necrosis (mm) achieved around a single fibre for a given light energy. We aim to achieve a 12mm zone of necrosis in the tumour. | — |
Countries
United Kingdom
Outcome results
None listed