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Status:

COMPLETED

Amifostine in Treating Young Patients With Newly Diagnosed De Novo Myelodysplastic Syndromes

Lead Sponsor:

Children's Oncology Group

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Myelodysplastic Syndromes

Myelodysplastic/Myeloproliferative Neoplasms

Eligibility:

All Genders

1-21 years

Phase:

PHASE2

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as amifostine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. PURPOSE: This phas...

Detailed Description

OBJECTIVES: Primary * Determine the hematologic effects of amifostine, in terms of, complete and partial response, in pediatric patients with newly diagnosed de novo myelodysplastic syndromes (MDS)....

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Histologically confirmed diagnosis of myelodysplastic syndromes (MDS)
  • One of the following subtypes:
  • Refractory anemia (RA)
  • RA with ringed sideroblasts
  • RA with excess blasts
  • Refractory cytopenia with multilineage dysplasia (RCMD)
  • RCMD and ringed sideroblasts
  • MDS, unclassified
  • MDS associated with isolated del 5(q)
  • De novo disease
  • No treatment-induced MDS
  • No juvenile myelomonocytic leukemia
  • No Down syndrome, Fanconi's anemia, or other inherited forms of hypoplastic bone marrow failure
  • PATIENT CHARACTERISTICS:
  • Age
  • 1 to 21 at original diagnosis
  • Performance status
  • Karnofsky 50-100% (patients \> 16 years of age)
  • Lansky 50-100% (patients 1 to 16 years of age)
  • Life expectancy
  • At least 8 weeks
  • Hematopoietic
  • See Disease Characteristics
  • Hepatic
  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • ALT \< 2.5 times ULN
  • Renal
  • Radioisotope glomerular filtration rate ≥ 60 mL/min OR
  • Creatinine clearance \> 60 mL/min (based on Schwartz formula)
  • Calcium normal
  • Other
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Serum electrolytes normal
  • Phosphorus normal
  • Magnesium normal
  • Glucose normal
  • No other concurrent malignancy
  • PRIOR CONCURRENT THERAPY:
  • Biologic therapy
  • More than 8 weeks since prior growth factors
  • No concurrent growth factors
  • No concurrent hematopoietic stem cell transplantation
  • No concurrent immunomodulating agents
  • Chemotherapy
  • No prior amifostine
  • No other concurrent anticancer chemotherapy
  • Endocrine therapy
  • No concurrent daily steroid therapy
  • Radiotherapy
  • Not specified
  • Surgery
  • Not specified
  • Other
  • No prior therapy for MDS

Exclusion

    Key Trial Info

    Start Date :

    January 1 2005

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    October 1 2009

    Estimated Enrollment :

    10 Patients enrolled

    Trial Details

    Trial ID

    NCT00098683

    Start Date

    January 1 2005

    End Date

    October 1 2009

    Last Update

    February 13 2014

    Active Locations (85)

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    Page 1 of 22 (85 locations)

    1

    Phoenix Children's Hospital

    Phoenix, Arizona, United States, 85016-7710

    2

    Arkansas Cancer Research Center at University of Arkansas for Medical Sciences

    Little Rock, Arkansas, United States, 72205

    3

    Jonathan Jaques Children's Cancer Center at Miller Children's Hospital

    Long Beach, California, United States, 90801

    4

    Children's Hospital Central California

    Madera, California, United States, 93638-8762