Human Immune Globulin in Treating Patients With Primary Amyloidosis That is Causing Heart Dysfunction

OBJECTIVES:

- Establish the maximum tolerated dose of human immune globulin intravenous (IGIV) given
weekly for the first 3 months and then bi-weekly for 9 additional months in patients
with cardiac-associated primary amyloidosis.

- Determine the safety, pharmakinetics, and therapeutic efficacy as evidenced by titers
of serum fibril-reactive IgG antibodies pre- and post-IGIV infusions.

- Demonstrate stable or improved organ function.

OUTLINE: Patients receive human immune globulin IV (IGIV) once weekly for 3 months and then
once biweekly for 9 months, for a total of 12 months in the absence of disease progression
or unacceptable toxicity.

Patients undergo blood sample collection to measure serum anti-fibril antibody titers pre-
and post- IGIV infusion for assessing safety and response to treatment.

DISEASE CHARACTERISTICS:

- Confirmed diagnosis of cardiac-associated primary (AL) amyloidosis based on accepted
clinical and laboratory criteria

- Patients must have heart involvement as evidenced by elevated serum brain natriuretic
peptide, troponin levels, and/or 2D echocardiography evidence of a thickened
intraventricular septum

- No non-AL amyloidosis

PATIENT CHARACTERISTICS:

- Life expectancy > 3 months

- No NYHA class IV heart disease

- No significant comorbidity (e.g., uncontrolled infection, diabetes, or other serious
illnesses)

PRIOR CONCURRENT THERAPY:

- Prior or concurrent chemotherapy or other drug-based anti-AL regimes allowed