Human Immune Globulin in Treating Patients With Primary Amyloidosis That is Causing Heart Dysfunction - Full Text View

Sponsor:	Baptist Regional Cancer Center at Baptist Riverside
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00547365

Purpose

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.

Condition	Intervention	Phase
Multiple Myeloma and Plasma Cell Neoplasm	Biological: therapeutic immune globulin Other: laboratory biomarker analysis	Phase I Phase II

Study Type:	Interventional
Study Design:	Primary Purpose: Treatment
Official Title:	Therapeutic Potential of Human Immune Globulin Intravenous (IGIV) in Patients With Cardiac-Associated AL Amyloidosis

Resource links provided by NLM:

Genetics Home Reference related topics: aceruloplasminemia hemophilia

MedlinePlus related topics: Amyloidosis Cancer Multiple Myeloma

Drug Information available for: Immunoglobulins Globulin, Immune

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Level of tolerance for human immune globulin intravenous (IGIV) as reflected by the number and severity of toxicity incidents [ Designated as safety issue: Yes ]
Clinical responses as evidenced by increased serum anti-fibril IgG antibody levels post-IGIV infusion and reduction (or no evident progression) in amyloid burden [ Designated as safety issue: No ]

Estimated Enrollment:	6
Study Start Date:	October 2007
Estimated Primary Completion Date:	October 2010 (Final data collection date for primary outcome measure)

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00547365

Locations

United States, Tennessee
Baptist Regional Cancer Center at Baptist Riverside	Recruiting
Knoxville, Tennessee, United States, 37901
Contact: Clinical Trials Office - Baptist Regional Cancer Center 865-632-5717
St. Mary's Medical Center	Recruiting
Powell, Tennessee, United States, 37849
Contact: Alan Solomon, MD 865-545-8126

Sponsors and Collaborators

Baptist Regional Cancer Center at Baptist Riverside

Investigators

Study Chair:

Alan Solomon, MD

St. Mary's Medical Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Alan Solomon, U.T. Medical Center Cancer Institute
ClinicalTrials.gov Identifier:	NCT00547365 History of Changes
Other Study ID Numbers:	CDR0000572104, BRCC-BHS-06127, UTCI-2645
Study First Received:	October 19, 2007
Last Updated:	August 21, 2009
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

primary systemic amyloidosis

Additional relevant MeSH terms:

Amyloidosis
Neoplasms
Multiple Myeloma
Neoplasms, Plasma Cell
Plasmacytoma
Proteostasis Deficiencies
Metabolic Diseases
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders

Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Antibodies
Immunoglobulins
Immunoglobulins, Intravenous
Rho(D) Immune Globulin
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012