Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II, Phase I Biomarker/Laboratory analysis, Treatment Active Adult Other BRCC-BHS-06127 UTCI-2645, 2645, NCT0054736

Objectives

1. 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.
2. Determine the safety, pharmakinetics, and therapeutic efficacy as evidenced by titers of serum fibril-reactive IgG antibodies pre- and post-IGIV infusions.
3. Demonstrate stable or improved organ function.

Entry Criteria

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

Prior/Concurrent Therapy:

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

Patient Characteristics:

• Life expectancy > 3 months
• No NYHA class IV heart disease
• No significant comorbidity (e.g., uncontrolled infection, diabetes, or other serious illnesses)

Expected Enrollment

Outcomes

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

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.

Trial Contact Information

Trial Lead Organizations

Baptist Regional Cancer Center at Baptist Hospital of East Tennessee

Alan Solomon, MD, Protocol chair		Ph: 865-305-9167

U.S.A.
Tennessee
	Knoxville
	Baptist Regional Cancer Center at Baptist Hospital of East Tennessee
		Clinical Trials Office - Baptist Regional Cancer Center	Ph:  865-632-5717

Registry Information
Official Title		Therapeutic Potential of Human Immune Globulin Intravenous (IGIV) in Patients With Cardiac-Associated AL Amyloidosis
Trial Start Date		2007-10-01
Registered in ClinicalTrials.gov		NCT0054736
Date Submitted to PDQ		2007-10-01
Information Last Verified		2008-08-08