Clinical Trial: Study of High-Dose Melphalan and Autologous Stem Cell Transplantation in Patients With Primary Light Chain Amyloidosis

This study is no longer recruiting patients.

Sponsored by: Herbert Irving Comprehensive Cancer Center
Information provided by: Office of Rare Diseases (ORD)

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.

Condition Treatment or Intervention Phase
Amyloidosis
 Drug: melphalan
 Procedure: Autologous Stem Cell Transplantation
Phase II

MedlinePlus related topics:  Metabolic Disorders

Study Type: Interventional
Study Design: Treatment

Further Study Details: 

Expected Total Enrollment:  25

Study start: July 1999

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.

Eligibility

Ages Eligible for Study:  18 Years   -   70 Years,  Genders Eligible for Study:  Both

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

Location Information


New York
      Herbert Irving Comprehensive Cancer Center, New York,  New York,  10032,  United States

Study chairs or principal investigators

Charles S. Hesdorffer,  Study Chair,  Herbert Irving Comprehensive Cancer Center   

More Information

Study ID Numbers:  199/15927; CPMC-IRB-9041; CPMC-CAMP-009A
Record last reviewed:  January 2005
Last Updated:  January 21, 2005
Record first received:  June 6, 2001
ClinicalTrials.gov Identifier:  NCT00017680
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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