Clinical Trial: Amifostine and Melphalan in Treating Patients With Primary Systemic Amyloidosis Who Are Undergoing Peripheral Stem Cell Transplantation

This study is currently recruiting patients.

Sponsors and Collaborators: Eastern Cooperative Oncology Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)

Purpose

RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Combining melphalan with a chemoprotective drug such as amifostine followed by peripheral stem cell transplantation may protect normal cells from the side effects of chemotherapy and may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of combining amifostine with melphalan in treating patients who are undergoing peripheral stem cell transplantation for primary systemic amyloidosis.

Condition Treatment or Intervention Phase
Drug Toxicity
primary systemic amyloidosis
 Drug: amifostine
 Drug: filgrastim
 Drug: melphalan
 Procedure: biological response modifier therapy
 Procedure: bone marrow ablation with stem cell support
 Procedure: chemoprotection
 Procedure: chemotherapy
 Procedure: colony-stimulating factor therapy
 Procedure: cytokine therapy
 Procedure: high-dose chemotherapy
 Procedure: peripheral blood stem cell transplantation
 Procedure: supportive care/therapy
Phase I

MedlinePlus related topics:  Metabolic Disorders;   Poisoning

Study Type: Interventional
Study Design: Treatment

Official Title: Phase I Study of Amifostine and High-Dose Melphalan in Patients With Primary Systemic Amyloidosis Undergoing Autologous Peripheral Blood Stem Cell Transplantation

Further Study Details: 

OBJECTIVES:

OUTLINE: This is a nonrandomized, multicenter, dose-escalation study of melphalan.

Patients receive filgrastim (G-CSF) subcutaneously once daily until peripheral blood stem cell (PBSC) collection is complete. Apheresis begins on day 5 of G-CSF administration and continues until the target number of PBSCs are collected.

Within 6 weeks of PBSC collection, patients receive amifostine IV over 5 minutes on days -2 and -1 and high-dose melphalan IV over 5 minutes on day -1. Patients undergo autologous PBSC infusion on day 0.

Cohorts of 3-6 patients receive escalating doses of melphalan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, an additional 10 patients are treated at that dose.

Patients are followed at day 100 post-transplantation, every 6 months for 5 years and then annually for 5 years.

PROJECTED ACCRUAL: A total of 3-46 patients will be accrued for this study within 2.3 years.

Eligibility

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

Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed amyloidosis
  • No secondary familial or localized amyloidosis
  • Presence of monoclonal protein by immunoelectrophoresis or immunofixation of serum or urine
  • No primary amyloidosis manifested only by carpal tunnel syndrome or purpura
  • Amyloid deposits in a plasmacytoma or in bone marrow vessels in an asymptomatic individual not considered an amyloid syndrome
  • Amyloid syndromes include any of the following:
  • Hepatomegaly
  • Cardiomyopathy
  • Nephrotic range proteinuria
  • Peripheral or autonomic neuropathy
  • No multiple myeloma defined by 1 of the following:
  • Presence of lytic bone disease
  • More than 30% bone marrow plasma cells

PATIENT CHARACTERISTICS: Age

  • 18 to 70

Performance status

  • ECOG 0-1

Life expectancy

  • Not specified

Hematopoietic

  • Platelet count at least 100,000/mm^3

Hepatic

  • See Disease Characteristics
  • Total or direct bilirubin no greater than 2.0 mg/dL
  • Alkaline phosphatase no greater than 4 times upper limit of normal

Renal

  • See Disease Characteristics
  • Creatinine less than 3.0 mg/dL

Cardiovascular

  • See Disease Characteristics
  • Ejection fraction at least 45% by echocardiogram
  • No New York Heart Association class III or IV heart disease

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No active infection
  • No other malignancy within the past 5 years except surgically treated carcinoma in situ of the cervix, nonmelanoma skin cancer, or indolent prostate cancer

PRIOR CONCURRENT THERAPY: Biologic therapy

  • At least 4 weeks since prior interferon

Chemotherapy

  • At least 4 weeks since prior melphalan
  • Lifetime total melphalan dose less than 150 mg/m^2 (based on ideal body weight)

Endocrine therapy

  • At least 4 weeks since prior dexamethasone

Radiotherapy

Surgery

  • Not specified

Other

  • No antihypertensive medications for at least 24 hours prior to, during, and for 1 hour after amifostine administration
  • No other prior treatment

Location and Contact Information


Arizona
      CCOP - Mayo Clinic Scottsdale Oncology Program, Scottsdale,  Arizona,  85259-5404,  United States; Recruiting
Tom Robert Fitch, MD  480-301-9875 

Florida
      Mayo Clinic - Jacksonville, Jacksonville,  Florida,  32224,  United States; Recruiting
Edith A. Perez, MD  904-953-7283    perez.edith@mayo.edu 

Indiana
      Indiana University Cancer Center, Indianapolis,  Indiana,  46202-5289,  United States; Recruiting
Rafat Abonour, MD  317-274-0843    rabonour@iupui.edu 

Minnesota
      CCOP - Metro-Minnesota, Saint Louis Park,  Minnesota,  55416,  United States; Recruiting
Patrick J. Flynn, MD  952-993-1517    patrick.flynn@usoncology.com 

      Mayo Clinic Cancer Center, Rochester,  Minnesota,  55905,  United States; Recruiting
Morie Abraham Gertz, MD  507-284-4102 

New Jersey
      CCOP - Northern New Jersey, Hackensack,  New Jersey,  07601,  United States; Recruiting
Scott D. Rowley, MD, FACP  201-996-5900 

Ohio
      MetroHealth's Cancer Care Center at MetroHealth Medical Center, Cleveland,  Ohio,  44106-5065,  United States; Recruiting
Hillard M. Lazarus, MD  216-844-1000    hml@po.cwru.edu 

Pennsylvania
      Abramson Cancer Center at the University of Pennsylvania, Philadelphia,  Pennsylvania,  19104-4283,  United States; Recruiting
Edward Allen Stadtmauer, MD  215-662-7910    edward.stadtmauer@uphs.upenn.edu 

Wisconsin
      Medical College of Wisconsin Cancer Center, Milwaukee,  Wisconsin,  53226-3596,  United States; Recruiting
David H. Vesole, MD, PhD  414-805-4626    dvesole@bmt.mcw.edu 

Study chairs or principal investigators

Morie Abraham Gertz, MD,  Study Chair,  Mayo Clinic Cancer Center   
David H. Vesole, MD, PhD,  Medical College of Wisconsin   
Philip R. Greipp, MD,  Mayo Clinic Cancer Center   

More Information

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

Study ID Numbers:  CDR0000258785; ECOG-E2A01
Record last reviewed:  August 2004
Last Updated:  April 4, 2005
Record first received:  January 24, 2003
ClinicalTrials.gov Identifier:  NCT00052884
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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