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Combination Chemotherapy in Treating Patients With Myelodysplastic Syndrome

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ClinicalTrials.gov Identifier: NCT00003827
Recruitment Status : Unknown
Verified July 2007 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : September 25, 2003
Last Update Posted : December 4, 2013
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. Chemoprotective drugs such as amifostine may protect normal cells from the side effects of chemotherapy.

PURPOSE: Phase II trial to study the effectiveness of combining topotecan and cytarabine given with amifostine in treating patients who have myelodysplastic syndrome.

Condition or disease Intervention/treatment Phase
Leukemia Myelodysplastic Syndromes Drug: amifostine trihydrate Drug: cytarabine Drug: topotecan hydrochloride Phase 2

Detailed Description:


  • Determine the toxic effects of amifostine, topotecan, and cytarabine in patients with poor risk myelodysplastic syndrome.
  • Determine the hematologic response rate, cytogenetic response rate, and the rate of polyclonal hematopoiesis following this treatment regimen.
  • Determine the duration of response and time to disease progression following this treatment regimen in these patients.

OUTLINE: Patients receive topotecan by continuous IV over 24 hours plus cytarabine IV over 2 hours, on days 1-5. Patients receive amifostine IV over 15 minutes every other day for a maximum of 60 days. Patients may receive a second course of the same regimen 8 weeks after the first.

Patients are followed at least monthly for 2 years, then every 3-6 months until death.

PROJECTED ACCRUAL: Approximately 25 patients will be accrued for this study within 1 to 1.5 years.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Primary Purpose: Treatment
Official Title: Treatment of Poor Risk Myelodysplasia With the Combination of Amifostine, Topotecan and ARA-C: A Phase II Study
Study Start Date : January 1999

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed poor risk myelodysplastic syndrome, including at least one of the following:

    • Bilineage cytopenia
    • Unfavorable cytogenetic abnormalities
    • Refractory anemia with excess blasts and/or refractory anemia with excess blast in transformation (greater than 5% blast)
  • At least 0.5 on the International Prognostic Score System
  • No chronic myelomonocytic leukemia
  • No hypocellular myelodysplastic syndrome (marrow cellularity less than 30%)



  • 16 and over

Performance status:

  • ECOG 0-1

Life expectancy:

  • Not specified


  • Absolute neutrophil count less than 1,500/mm3
  • Platelet count less than 100,000/mm3
  • Hemoglobin less than 10 g/dL


  • ALT less than 5 times upper limit of normal


  • Creatinine no greater than 1.4 mg/dL


  • No congestive heart failure


  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • Must have right atrial catheter inserted


Biologic therapy:

  • No prior blood or bone marrow transplantations


  • No prior acute myeloid leukemia chemotherapy (except hydroxyurea or low dose cytarabine)
  • No prior topotecan
  • No prior amifostine

Endocrine therapy:

  • Not specified


  • Not specified


  • Not specified


  • At least 24 hours since prior antihypertensive medication prior to amifostine

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003827

United States, California
Cancer Center and Beckman Research Institute, City of Hope
Duarte, California, United States, 91010-3000
Sponsors and Collaborators
Study Chair: Henry C. Fung, MD, FRCPE City of Hope Comprehensive Cancer Center

ClinicalTrials.gov Identifier: NCT00003827     History of Changes
Other Study ID Numbers: CDR0000066982
First Posted: September 25, 2003    Key Record Dates
Last Update Posted: December 4, 2013
Last Verified: July 2007

Keywords provided by National Cancer Institute (NCI):
refractory anemia with excess blasts
refractory anemia with excess blasts in transformation
de novo myelodysplastic syndromes
secondary myelodysplastic syndromes
childhood myelodysplastic syndromes

Additional relevant MeSH terms:
Myelodysplastic Syndromes
Pathologic Processes
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Radiation-Protective Agents
Protective Agents