Clinical Trial: High-Dose Melphalan Followed by Peripheral Stem Cell Transplantation in Treating Patients With Amyloidosis

This study is currently recruiting patients.

Sponsored by: Fox Chase Cancer Center
Information provided by: National Cancer Institute (NCI)

Purpose

RATIONALE: Chemotherapy and peripheral stem cell transplantation may be effective in treating patients with amyloidosis.

PURPOSE: This phase II trial is studying how well giving high-dose melphalan together with peripheral stem cell transplantation works in treating patients with primary amyloidosis or amyloidosis associated with multiple myeloma.

Condition Treatment or Intervention Phase
refractory plasma cell neoplasm
stage I multiple myeloma
stage II multiple myeloma
stage III multiple myeloma
primary systemic amyloidosis
 Drug: filgrastim
 Drug: melphalan
 Procedure: biological response modifier therapy
 Procedure: bone marrow ablation with stem cell support
 Procedure: chemotherapy
 Procedure: colony-stimulating factor therapy
 Procedure: cytokine therapy
 Procedure: high-dose chemotherapy
 Procedure: peripheral blood stem cell transplantation
Phase II

MedlinePlus related topics:  Immune System and Disorders;   Lymphatic Diseases;   Metabolic Disorders;   Multiple Myeloma

Study Type: Interventional
Study Design: Treatment

Official Title: Phase II Study of High-Dose Melphalan Followed by Autologous Peripheral Blood Stem Cell Transplantation in Primary Amyloidosis or Amyloidosis Secondary to Multiple Myeloma

Further Study Details: 

OBJECTIVES:

OUTLINE: Peripheral blood stem cells (PBSC) are mobilized with granulocyte colony-stimulating factor (G-CSF) for 5 days and then collected by leukapheresis. Patients receive high-dose melphalan on 2 consecutive days, followed by 1 day of rest, then by PBSC transplantation. G-CSF is given from 1 day after transplantation until the neutrophil count is greater than 1,500 for 3 consecutive days.

Patients are followed at 100 days and 1 year post-transplant.

PROJECTED ACCRUAL: A very small number of patients are expected to be accrued over 5-10 years.

Eligibility

Ages Eligible for Study:  16 Years   -   65 Years,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

PATIENT CHARACTERISTICS: Age:

  • 16 to 65

Performance status:

  • Karnofsky 80-100%

Hematopoietic:

  • Not specified

Hepatic:

  • Liver function tests less than twice normal
  • No active liver disease

Renal:

  • Creatinine clearance greater than 50 mL/min
  • Nephrotic syndrome allowed

Cardiovascular:

  • Cardiac evaluation required in patients with left ventricular ejection fraction less than 45% by echocardiogram or MUGA
  • No poorly controlled hypertension

Pulmonary:

Other:

  • No history of serious coagulopathy, hemorrhage, or bleeding
  • No active infection
  • No other serious comorbid disease (e.g., poorly controlled diabetes)
  • No pregnant women
  • Adequate contraception required of fertile women

PRIOR CONCURRENT THERAPY: Biologic therapy:

  • Not specified

Chemotherapy:

Endocrine therapy:

  • Corticosteroids discontinued at least 6 weeks prior to transplantation

Radiotherapy:

  • No prior radiotherapy

Surgery:

  • Not specified

Location and Contact Information


Pennsylvania
      Fox Chase - Temple Cancer Center, Philadelphia,  Pennsylvania,  19111-2442,  United States; Recruiting
Kenneth F. Mangan, MD  215-214-3129    mangank@tuhs.temple.edu 

Study chairs or principal investigators

Kenneth F. Mangan, MD,  Study Chair,  Fox Chase Cancer Center   

More Information

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

Study ID Numbers:  CDR0000064938; TUHSC-2797; NCI-V96-0951; NCT00002810
Record last reviewed:  September 2003
Last Updated:  February 24, 2005
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00002810
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


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

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