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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Therapeutic Potential of Human Immune Globulin Intravenous (IGIV) in Patients With Cardiac-Associated Light Chain (AL) Amyloidosis

Brief Summary:

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.


Detailed Summary:

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 light chain-associated (AL) amyloidosis.
  • Determine the safety, pharmokinetics, and therapeutic efficacy as evidenced by titers of serum fibril-reactive immunoglobulin G (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.


Sponsor: University of Tennessee

Current Primary Outcome:

  • Tolerance for Human Immune Globulin Intravenous (IGIV), as Reflected by the Number and Severity of Toxicity Incidents Occurring in Ten Patients Receiving at Least One Infusion of IGIV. [ Time Frame: Up to 1 year ]
  • Clinical Response of Patients With Cardiac-dominant AL Amyloidosis Given Human Immune Globulin Intravenous (IGIV) [ Time Frame: Up to 1 year ]
    Positive clinical response was defined by improvement in heart function in participating patients with cardiac-dominant AL amyloidosis, as demonstrated by increased serum anti-fibril immunoglobulin G (IgG) antibody levels and reduction (or no evident progression) in amyloid burden.


Original Primary Outcome:

  • 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


Current Secondary Outcome:

Original Secondary Outcome:

Information By: University of Tennessee

Dates:
Date Received: October 19, 2007
Date Started: October 2007
Date Completion:
Last Updated: September 16, 2013
Last Verified: September 2013