Expired Study
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New York, New York 10032


Purpose:

OBJECTIVES: I. Determine the response, disease-free survival, and overall survival of patients with primary light chain amyloidosis treated with high-dose melphalan and autologous stem cell transplantation. II. Determine the toxicity of this regimen in these patients.


Study summary:

PROTOCOL OUTLINE: Patients may receive induction chemotherapy before study entry. Patients then receive filgrastim (G-CSF) or another growth factor for 4-6 days as peripheral blood stem cell (PBSC) mobilization. PBSC (or bone marrow) is harvested over 2-3 days. Patients receive high-dose melphalan IV over 30 minutes twice daily on days -2 and -1. PBSC and/or bone marrow is reinfused on day 0. Patients receive G-CSF beginning on day 0 and continuing until blood counts recover. This course may be repeated 4-12 weeks later. Patients are followed every 3 months for 1 year and then annually for 5 years.


Criteria:

PROTOCOL ENTRY CRITERIA: Disease Characteristics - Histologically confirmed primary amyloidosis - Ineligible for other high priority national or international study Prior/Concurrent Therapy - Biologic therapy: Concurrent participation in gene therapy trials allowed - Chemotherapy: Prior chemotherapy allowed No other concurrent chemotherapy - Endocrine therapy: No concurrent steroids unless given with amphotericin B, for adrenal failure, or for septic shock No concurrent hormones except for non-disease-related conditions (e.g., insulin for diabetes) - Other: No concurrent barbiturates or acetaminophen Concurrent participation in supportive care trials allowed Patient Characteristics - Performance status: ECOG 0-3 - Hepatic: Bilirubin less than 2 times normal - Renal: Creatinine less than 2.5 mg/dL OR On stable hemodialysis - Pulmonary: DLCO at least 60% predicted OR Clearance by pulmonologist - Other: HIV negative


NCT ID:

NCT00017680


Primary Contact:

Study Chair
Charles S. Hesdorffer
Herbert Irving Comprehensive Cancer Center


Backup Contact:

N/A


Location Contact:

New York, New York 10032
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 21, 2017

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