Combination Chemotherapy in Treating Patients With Myelodysplastic Syndrome

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2007 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00003827
First received: November 1, 1999
Last updated: December 3, 2013
Last verified: July 2007
  Purpose

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:

OBJECTIVES:

  • 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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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%)

PATIENT CHARACTERISTICS:

Age:

  • 16 and over

Performance status:

  • ECOG 0-1

Life expectancy:

  • Not specified

Hematopoietic:

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

Hepatic:

  • ALT less than 5 times upper limit of normal

Renal:

  • Creatinine no greater than 1.4 mg/dL

Cardiovascular:

  • No congestive heart failure

Other:

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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No prior blood or bone marrow transplantations

Chemotherapy:

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

Endocrine therapy:

  • Not specified

Radiotherapy:

  • Not specified

Surgery:

  • Not specified

Other:

  • 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 ClinicalTrials.gov identifier: NCT00003827

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

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00003827     History of Changes
Other Study ID Numbers: CDR0000066982, CHNMC-IRB-98056, ALZA-CHNMC-IRB-98056, NCI-V99-1533
Study First Received: November 1, 1999
Last Updated: December 3, 2013
Health Authority: United States: Federal Government

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:
Leukemia
Myelodysplastic Syndromes
Preleukemia
Neoplasms by Histologic Type
Neoplasms
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Cytarabine
Topotecan
Amifostine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Protective Agents
Protective Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on August 20, 2014