OPEN: FEASIBILITY STUDY (PHASE I) FOR USE OF NANO-CANCER THERAPY TO TREAT PANCREATIC CARCINOMA

This phase I study of patients with non-resectable and/or metastasized pancreatic carcinoma should demonstrate whether the introduction of magnetic nanoparticle fluid into the tumor is technically feasible, whether the target temperatures can be repeatably attained with sufficient homogeneity and over a sufficient area, and what side effects arise in combination with chemotherapy. The study will also examine the molecular biological processes, specific tumor genes, and the absorption of nanoparticles into tissue.

STUDY TITLE

Pilot study on using thermotherapy with magnetic nanoparticles to treat non-resectable pancreatic carcinoma

PRINCIPAL INVESTIGATOR

Prof. Dr. Beate Rau, Charité Campus Mitte, Clinic for General, Abdominal, Thoracic and Vascular Surgery

STUDY START

November 2007

INCLUSION CRITERIA

• Histological or cytological confirmation of a pancreatic carcinoma which appears to be non-resectable and/or which will not be resected because of histologically confirmed distant metastatis (determined either through staging laparoscopy as part of an exploratory laparoscopy, or through CT scan)

• Non-resectable and/or M1

• Patient declaration of consent

EXCLUSION CRITERIA

• Age > 75 years
• Karnofsky Index ≤ 60%, WHO activity status ≤ 2
• Tumor fistula in gastrointestinal tract
• Manifest respiratory insufficiency despite medication (paO2 < 55 mm Hg, FEV1 < 60%, vital capacity < 60%)
• Florid infection
• Manifest cardiac insufficiency despite therapy (NYHA stage > II), acute coronary syndrome within the past three months
• Manifest renal insufficiency despite therapy (computed creatinine clearance ≤ 50 ml/min)
• Manifest hepatic insufficiency (liver cirrhosis graded Child B or C)
• Gastrointestinal bleeding
• Manifest neurological and/or psychiatric disturbances, incapacity to provide consent
• Insufficient bone marrow reserves (leukocytes < 3.0 G/l, thrombocytes < 100 G/l)
  
• Metal devices in the thorax, neck or upper abdomen (e.g. pacemaker, IV port, defibrillator, metal bile duct stent) which would preclude treatment with the magnetic field applicator 
• Other life-threatening illness with impaired vital function
• Participation in other studies
• Pregnancy, lactation, or desire to have children