PCIA202-10 Phase 2 Amphinex-based PCI of Bleomycin

• Research type

  Research Study

• Full title

  An open-label, single arm, multi-centre, Phase II study to evaluate the safety and efficacy of PC-A11 with superficial and interstitial laser light application in patients with recurrent head and neck squamous cell carcinoma unsuitable for surgery and radiotherapy and without distant metastases

• IRAS ID

  94515

• Contact name

  Colin Hopper

• Eudract number

  2011-003751-19

• ISRCTN Number

  not known

• Research summary

  The aim of this study is to test the effectiveness and safety of PC-A11 in patients with recurrent squamous head and neck cancer unsuitable for surgery or radiotherapy and which has not spread to distant areas. PC-A11 represents a novel treatment, called Photochemical Internalisation (PCI). PC-A11 consists of Amphinex©, a photosensitive agent, and the chemotherapy agent, Bleomycin. PC-A11 will be administered as a single dose. By applying laser light to the skin for superficial tumours, or via needles inserted directly into the cancer cells for tumours located below the surface, PC-A11 will be activated, resulting in the destruction of the cancer cells. This procedure will take place under general anaesthesia. A clinical study with PC-A11 has been performed previously. The results showed that Amphinex was well tolerated without major safety concerns, and the treatment looked promising in terms of its effect on tumour shrinkage. The study will be conducted as an open-label, single arm study and will take place in the UK, The Netherlands, France and Germany. After an initial screening to determine patients?? suitability to participate, patients will be hospitalised for 7 days for treatment and recovery. During the screening and hospitalisation, many tests will be performed, for example, a physical examination, blood- and urine tests, electrocardiogram (ECG), Computed Tomography (CT) or Magnet Resonance Imaging (MRI). After treatment, patients will be required to visit the hospital roughly every 6 weeks for their progress to be followed and to determine the effect of PC-A11 on the size of the tumour.Possible side-effects include temporarily light-sensitivity of skin and eyes due to effect of Amphinex. Other side-effects are those associated with chemotherapy agents, such as nausea, vomiting, and hair-loss. However, as bleomycin is only administered once, these side effects should be less severe than for standard chemotherapy.

• REC name

  London - Chelsea Research Ethics Committee

• REC reference

  12/LO/0402

• Date of REC Opinion

  2 May 2012

• REC opinion

  Further Information Favourable Opinion