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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

Status: Recruiting

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

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.

Clinical Details

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

Study design: Primary Purpose: Treatment

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

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

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

Additional Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: October 2007
Last updated: August 21, 2009

Page last updated: February 07, 2013

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