Phase II Trial of 4'-IODO-4'-Deoxydoxorubicin in Primary Amyloidosis (AL)

Inclusion Criteria

DISEASE CHARACTERISTICS: Histochemically proven primary systemic amyloidosis (AL) No
presence of non-AL amyloidosis No amyloid-specific syndrome (e.g., skin purpura or carpal
tunnel syndrome) as only evidence of disease No vascular amyloid only in a bone marrow
biopsy specimen or in a plasmacytoma Must have symptomatic organ involvement with amyloid
(e.g., liver, mild cardiac, renal, or soft tissue involvement, or grade 1 or 2 peripheral
neuropathy) Demonstrable M-protein in the serum/urine OR Clonal population of plasma cells
in the bone marrow OR Immunohistochemical stain with anti-light chain antisera of amyloid
fibrils No clinically overt multiple myeloma (i.e., monoclonal BMPC greater than 20% and
at least one of the following: bone lesions, anemia, or hypercalcemia)

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-3 Life expectancy:
Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count
at least 100,000/mm3 Hepatic: Total bilirubin less than 2.0 mg/dL OR Direct bilirubin no
greater than 1.0 mg/dL Alkaline phosphatase no greater than 4 times upper limit of normal
(ULN) ALT or AST no greater than 3 times ULN Renal: Creatinine clearance greater than 40
mL/min Cardiovascular: Echocardiographic ejection fraction greater than 50% At least 3
years since prior enzyme documented myocardial infarction Interventricular septal
thickness no greater than 20 mm No New York Heart Association class III or IV heart
failure No grade 2 or 3 A-V block No chronic atrial fibrillation No sustained (greater
than 30 seconds) ventricular tachycardia or frequent episodes (greater than 20 in 24
hours) of nonsustained ventricular tachycardia or ventricular pairs, detected by 24-hour
ambulatory electrocardiographic monitoring Other: Not pregnant or nursing Negative
pregnancy test Fertile patients must use effective contraception HIV positive allowed No
uncontrolled infection No severe diarrhea not controllable with medication or that
requires total parenteral nutrition No other concurrent active malignancy except
nonmelanoma skin cancer or cervical cancer

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 6 weeks since prior interferon alfa
Chemotherapy: No prior anthracyclines greater than 120 mg/m2 At least 6 weeks since prior
melphalan or other alkylating agents Endocrine therapy: At least 6 weeks since prior high
dose dexamethasone Radiotherapy: Not specified Surgery: Not specified