Iododoxorubicin in Treating Patients With Primary Systemic Amyloidosis

• Status: Terminated
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Iododoxorubicin may dissolve protein deposits and be an effective treatment for primary systemic amyloidosis. Phase I trial to determine the effectiveness of iododoxorubicin in treating patients who have primary systemic amyloidosis

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Doxorubicin; Esorubicin

Criteria

Inclusion Criteria:

• Histochemically confirmed amyloidosis by polarizing microscopy of greenbirefringent material in Congo red-stained tissue specimens

• At least one of the following:

• Demonstrable M-protein in serum or urine

• Clonal population of plasma cells in bone marrow

• Immunohistochemical stain with anti-light chain antisera of amyloid fibrils

• Symptomatic organ involvement, including liver involvement, mild cardiac involvement, renal involvement, grade 1 or 2 peripheral neuropathy, or soft tissue involvement (including tongue)

• No purpura or carpal tunnel syndrome as sole manifestation of disease

• No clinically overt multiple myeloma defined as monoclonal bone marrow platelet concentration greater than 20% and at least one of the following:

• Bone lesions

• Anemia

• Hypercalcemia

• Performance status - ECOG 0-3 (3 allowed only if related to muscular infiltration by amyloid or peripheral neuropathy)

• Platelet count at least 100,000/mm^3

• Absolute neutrophil count at least 1,500/mm^3

• Total bilirubin no greater than 2.0 mg/dL

• Direct bilirubin no greater than 1.0 mg/dL

• Alkaline phosphatase no greater than 4 times upper limit of normal (ULN)

• AST or ALT no greater than 3 times ULN

• Creatinine clearance at least 40 mL/min

• Ejection fraction at least 50% by echocardiogram

• No New York Heart Association class III or IV heart disease

• No enzyme-documented myocardial infarction within the past 3 years

• No chronic atrial fibrillation

• No grade 2 or 3 atrioventricular block (Mobitz type I allowed)

• No sustained (greater than 30 seconds) ventricular tachycardia, more than 1 episode of non-sustained ventricular tachycardia (3 consecutive ventricular beats), or frequent (more than 20 in 24 hours) ventricular pairs by 24-hour ambulatory electrocardiographic monitoring

• No intraventricular septum greater than 16 mm by echocardiogram

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No uncontrolled infection

• No other active malignancy except nonmelanoma skin cancer or cervical cancer

• No psychiatric illness or social situation that would preclude study

• No severe diarrhea (greater than grade 3) that is not controllable with medication or that requires total parenteral nutrition

• More than 4 weeks since prior interferon alfa

• No concurrent immunotherapy

• More than 4 weeks since prior melphalan or other alkylating agents

• No prior anthracycline exposure greater than 120 mg/m^2

• Recovered from prior chemotherapy

• No other concurrent chemotherapy

• More than 4 weeks since prior high-dose dexamethasone

• No concurrent radiotherapy

• No concurrent investigational ancillary therapy