Light dose escalation trial of PDT in soft tissue sarcoma

• Research type

  Research Study

• Full title

  A phase II, open label, single site light dose escalation trial of single dose Verteporfin Photodynamic Therapy (PDT) in primary soft tissue sarcoma

• IRAS ID

  46411

• Contact name

  Tim Briggs

• Sponsor organisation

  Research & Development Department

• Eudract number

  2010-019714-24

• ISRCTN Number

  n/a

• Research summary

  This is a phase II study recruiting patients diagnosed with primary soft tissue sarcoma (cancer) to treatment with photodynamic therapy (PDT) combined with routine tumour excision. We believe that PDT can reduce local tumour recurrence and maintain limb function. This initial trial is to determine the correct light dose required to kill a 12mm zone of tumour. This will be assessed using histological analysis of the tumour excised at surgery (the normal treatment for sarcoma) and the normal tissues found in the margins and correlated to MRI findings. PDT involves intravenously injecting the photosensitizer Verteporfin (Visudyne) drug that has affinity to malignant cells. This drug makes the tumour sensitive to light. A non thermal light will then be shone in the tumour which brings about tissue death. An MRI will be performed 4-5days after the PDT. The patients will proceed to conventional surgery. Pre and post PDT MRI changes will be confirmed with the histological findings. When the appropriate light dose is established recruitment will continue until 10 patients have received this dose. These 10 patients will provide sample data on the area of necrosis detected by MRI and histology to enable appropriate treatment parameters to be chosen for future studies of PDT in soft tissue sarcoma.Objectives:1. To study the photobiology of Photodynamic Therapy (PDT) on soft tissue sarcoma. We aim to establish the minimum light intensity required to induce an area of necrosis with a diameter of at least 12mm.2. To look at the effect of Photodynamic Therapy on the normal surrounding tissues.3. To assess the response of the sarcoma using post treatment MRI and compare with histology. PDT has been used in many other types of cancer with encouraging results and minimal side-effects and we hope to see similar results with it in treatment for sarcomas.

• REC name

  South Central - Oxford A Research Ethics Committee

• REC reference

  10/H0604/46

• Date of REC Opinion

  2 Sep 2010

• REC opinion

  Further Information Favourable Opinion