Phase II Trial of 4'-IODO-4'-Deoxydoxorubicin in Primary Amyloidosis (AL)
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
PROJECTED ACCRUAL: A total of 45 patients will be accrued for this study within 1 year.
Primary Purpose: Treatment
Morie A. Gertz, MD
United States: Federal Government
|Mayo Clinic Cancer Center||Rochester, Minnesota 55905|
|University of Arkansas for Medical Sciences||Little Rock, Arkansas 72205|