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A multicenter phase II trial of 4'-iodo-4'deoxydoxorubicin (IDOX) in primary amyloidosis (AL).
Gertz MA, Lacy MQ, Dispenzieri A, Cheson BD, Barlogie B, Kyle RA, Palladini G, Geyer SM, Merlini G.
Division of Hematology and Internal Medicine, Mayo Clinic, Rochester, MN 55905, USA. gertm@mayo.edu
INTRODUCTION: 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 CONCLUSION: IDOX administered in this protocol was insufficiently active at the current dose.
Publication Types:
- Clinical Trial
- Clinical Trial, Phase II
- Multicenter Study
PMID: 12000194 [PubMed - indexed for MEDLINE]
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