Human Immune Globulin in Treating Patients With Primary Amyloidosis That is Causing Heart Dysfunction
The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by National Cancer Institute (NCI).
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Baptist Regional Cancer Center at Baptist Riverside
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00547365
First received: October 19, 2007
Last updated: August 21, 2009
Last verified: August 2009
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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 1 Phase 2 |
| 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:
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) |
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:
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 May 23, 2013