title: A multicenter phase II trial of 4'-iodo-4'deoxydoxorubicin (IDOX) in primary amyloidosis (AL).
abstract: BACKGROUND
  4'-Iodo-4'-deoxydoxorubicin (IDOX) has been reported to bind to and lead to the catabolism of amyloid deposits. A multicenter study attempted to develop a dosing schedule to confirm those results.
  
  
  METHODS
  Patients with biopsy-proven amyloidosis were required to have a cardiac ejection fraction > 50%, ventricular septal thickness < 20 mm, serum creatinine < 2.5 mg per dL, bilirubin < or = 2.0 mg per dL, neutrophils > 1,500 per microL, and platelets > 100,000 per microL. IDOX was administered intravenously over 1 hour at a dose of 15 mg per m2 once a week for 4 consecutive weeks. This therapy was repeated every 3 months up to 4 times.
  
  
  RESULTS
  Twenty-five previously treated and 15 untreated patients with primary amyloidosis (AL) received therapy. Fifteen patients had > 3 g of protein per day in the urine. Eleven patients had an ejection fraction < 60%. One, 2, 3, 4, and 5 organ systems were involved in 22, 10, 4, 3, and 1 patient, respectively. The median time between diagnosis and initiation of IDOX was 17.4 months. There were 6 responses (15%). Twelve of the patients have died
  
  
  CONCLUSIONS
  IDOX administered in this protocol was insufficiently active at the current dose.
authors: Division of Hematology and Internal Medicine, Mayo Clinic, Rochester, MN 55905, USA. gertm@mayo.edu
authors: Morie A
authors: MA
authors: Gertz
authors: Martha Q
authors: MQ
authors: Lacy
authors: Angela
authors: A
authors: Dispenzieri
authors: Bruce D
authors: BD
authors: Cheson
authors: Bart
authors: B
authors: Barlogie
authors: Robert A
authors: RA
authors: Kyle
authors: Giovanni
authors: G
authors: Palladini
authors: Susan M
authors: SM
authors: Geyer
authors: Giampaolo
authors: G
authors: Merlini
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000686:Amyloidosis / Q000188:drug therapy*; D004317:Doxorubicin / Q000031:analogs & derivatives / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged
chemical_list: C053044:4'-deoxy-4'-iododoxorubicin; D004317:Doxorubicin