Human Immune Globulin in Treating Patients With Primary Amyloidosis That is Causing Heart Dysfunction
Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Multiple Myeloma and Plasma Cell Neoplasm
Intervention: therapeutic immune globulin (Biological); laboratory biomarker analysis (Other)
Phase: Phase 1/Phase 2
Sponsored by: Baptist Regional Cancer Center at Baptist Riverside
Official(s) and/or principal investigator(s):
Alan Solomon, MD, Study Chair, Affiliation: St. Mary's Medical Center
RATIONALE: Antibodies, such as human immune globulin, can block the growth of abnormal cells
in different ways. Some block the ability of abnormal cells to grow and spread. Others find
abnormal cells and help kill them or carry cell-killing substances to them. Giving human
immune globulin may be effective in treating patients with primary amyloidosis that is
causing heart dysfunction.
PURPOSE: This phase I/II trial is studying the side effects and best dose of human immune
globulin and to see how well it works in treating patients with primary amyloidosis that is
causing heart dysfunction.
Official title: Therapeutic Potential of Human Immune Globulin Intravenous (IGIV) in Patients With Cardiac-Associated AL Amyloidosis
Study design: Primary Purpose: Treatment
Level of tolerance for human immune globulin intravenous (IGIV) as reflected by the number and severity of toxicity incidents
Clinical responses as evidenced by increased serum anti-fibril IgG antibody levels post-IGIV infusion and reduction (or no evident progression) in amyloid burden
- 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.
Minimum age: 18 Years.
Maximum age: N/A.
- 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
- No non-AL amyloidosis
- Life expectancy > 3 months
- No NYHA class IV heart disease
- No significant comorbidity (e. g., uncontrolled infection, diabetes, or other serious
PRIOR CONCURRENT THERAPY:
- Prior or concurrent chemotherapy or other drug-based anti-AL regimes allowed
Locations and Contacts
Baptist Regional Cancer Center at Baptist Riverside, Knoxville, Tennessee 37901, United States; Recruiting
Clinical Trials Office - Baptist Regional Cancer Center, Phone: 865-632-5717
St. Mary's Medical Center, Powell, Tennessee 37849, United States; Recruiting
Alan Solomon, MD, Phone: 865-545-8126
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: October 2007
Last updated: August 21, 2009