4'-Iodo-4'-Deoxydoxorubicin in Treating Patients With Primary Systemic Amyloidosis
RATIONALE: 4'-Iodo-4'-deoxydoxorubicin may improve organ dysfunction and ease symptoms caused by primary systemic amyloidosis.
PURPOSE: Phase II trial to study the effectiveness of 4'-iodo-4'-deoxydoxorubicin in treating patients who have primary systemic amyloidosis.
|Multiple Myeloma and Plasma Cell Neoplasm||Drug: 4'-iodo-4'-deoxydoxorubicin||Phase 2|
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Phase II Trial of 4'-IODO-4'-Deoxydoxorubicin in Primary Amyloidosis (AL)|
|Study Start Date:||April 1999|
|Study Completion Date:||August 2001|
|Primary Completion Date:||August 2000 (Final data collection date for primary outcome measure)|
OBJECTIVES: I. Evaluate the clinical efficacy of 4'-iodo-4'-deoxydoxorubicin in producing palliation of symptoms and/or improvement of organ dysfunction caused by organ infiltration by amyloid in patients with primary systemic amyloidosis. II. Assess the safety profile, with emphasis on cardiac safety, of this drug in these patients. III. Evaluate the time to progression of amyloidosis-associated clinical symptoms and/or organ dysfunction, duration of response, and survival of these patients on this regimen.
OUTLINE: Patients receive 4'-iodo-4'-deoxydoxorubicin IV over 1 hour once a week for 4 weeks. Courses are repeated every 12 weeks. Treatment continues for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 6 months.
PROJECTED ACCRUAL: A total of 45 patients will be accrued for this study within 1 year.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003853
|United States, Arkansas|
|University of Arkansas for Medical Sciences|
|Little Rock, Arkansas, United States, 72205|
|United States, Minnesota|
|Mayo Clinic Cancer Center|
|Rochester, Minnesota, United States, 55905|
|University of Pavia|
|Pavia, Italy, 27100|
|Study Chair:||Morie A. Gertz, MD||Mayo Clinic|