Iododoxorubicin in Treating Patients With Primary Systemic Amyloidosis

Stopped early · Phase 1

Conditions studied: Primary Systemic Amyloidosis

In brief

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

Key facts

Study ID

NCT00030381

Run by

National Cancer Institute (NCI)

People needed

22

Starts

2001-12-01

Last updated by the study team

2013-01-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

Where it is running

• Mayo Clinic — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.