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Combination Chemotherapy in Treating Patients With Myelodysplastic Syndrome

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2007 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
Information provided by:
National Cancer Institute (NCI) Identifier:
First received: November 1, 1999
Last updated: December 3, 2013
Last verified: July 2007

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 Intervention Phase
Leukemia Myelodysplastic Syndromes Drug: amifostine trihydrate Drug: cytarabine Drug: topotecan hydrochloride Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Treatment of Poor Risk Myelodysplasia With the Combination of Amifostine, Topotecan and ARA-C: A Phase II Study

Resource links provided by NLM:

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 25
Study Start Date: January 1999
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.


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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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
  More Information Identifier: NCT00003827     History of Changes
Other Study ID Numbers: CDR0000066982
Study First Received: November 1, 1999
Last Updated: December 3, 2013

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 processed this record on August 18, 2017