NCT01606566

A Study to Evaluate the Safety and Efficacy of Amphinex Induced PCI of Bleomycin for Recurrent Head and Neck Cancer.

Open-label, Single Arm, Multi-centre, Phase II Study to Evaluate the Safety and Efficacy of Amphinex Induced PCI of Bleomycin With Superficial and Interstitial Laser Light Application in Patients With Recurrent Head and Neck Cancer

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: PCI Biotech AS · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy and safety of Amphinex induced PCI of bleomycin ('PC-A11') with superficial and/or interstitial laser light application in patients with recurrent SCCHN.

Detailed description

Approximately 650 000 new cases of head and neck cancer are diagnosed worldwide each year (2). Europe alone, it is estimated that there are approximately 143 000 new cases and more than 68 000 deaths each year (3). The vast majority (\>90%) of head and neck malignancies are squamous cell carcinomas. Most (60-70%) patients with squamous cell carcinoma of the head and neck (SCCHN) present with loco regionally advanced disease. Standard treatment options for SCCHN include surgery, radiotherapy and chemotherapy. Single-modality treatment with surgery or radiotherapy is generally recommended for the 40% of patients who present stage I or II disease. Each of the two modalities results in similar survival with cure rates ranging between 60% and 90%. For the 60% of the patients who present with locally advanced disease at diagnosis, combined modality therapy is generally recommended. For patients with unresectable disease the current standard treatment is concurrent cisplatin-based chemoradiation. This is also the standard for patients with resectable disease when organ preservation is desired and, as adjuvant treatment, for patients with high-risk pathological findings at surgical resection. Despite such an approach, a substantial percentage of patients (20-30%) develop local and/or regional recurrences and distant metastases. Recurrent disease is often not resectable, and even in resectable cases, some patients decline the surgical procedure due to quality of life considerations. Additionally, in recurrent disease the radiation tolerance of the normal tissues makes re-irradiation technically challenging and frequently more toxic than the initial course. The prognosis of patients with recurrent or metastatic SCCHN is generally poor, with a median survival of 6-9 months. The therapeutic ratio in recurrent SCCHN is narrow. Therefore, there is a large unmet medical need for novel treatments in this patient group, both to lengthen overall survival, and to improve the patients' quality of life.

Conditions

• Recurrent Head and Neck Cancer
• Carcinoma, Squamous Cell of Head and Neck

Interventions

Type	Name	Description
DRUG	Amphinex induced PCI of bleomycin	Intravenous administration of 0.25 mg/kg Amphinex (day 0) followed by intravenous administration of bleomycin (15000 IU/m2, day 4) and laser light application (3 hours (+/- 1 hour) after bleomycin administration).

Timeline

• Start date: 2012-04-01
• Primary completion: 2015-08-01
• Completion: 2016-01-01
• First posted: 2012-05-25
• Last updated: 2022-02-18

Locations

10 sites across 6 countries: France, Germany, Lithuania, Netherlands, Poland, United Kingdom