Combination Chemotherapy in Treating Patients With Myelodysplastic Syndrome
Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on May 09, 2007
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Leukemia
Intervention: amifostine trihydrate (Drug); cytarabine (Drug); topotecan hydrochloride (Drug); chemoprotection (Procedure); chemotherapy (Procedure); supportive care/therapy (Procedure)
Phase: Phase 2
Status: No longer recruiting
Sponsored by: ALZA Official(s) and/or principal investigator(s):
Henry C. Fung, MD, FRCPE, Study Chair, Affiliation: Beckman Research Institute
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.
Clinical Details
Official title:
Treatment of Poor Risk Myelodysplasia With the Combination of Amifostine, Topotecan and ARA-C: A Phase II Study
Study design: Interventional, Treatment
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
Minimum age: 16 Years.
Gender(s): Both.
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
Locations and Contacts
Cancer Center and Beckman Research Institute, City of Hope, Duarte, California 91010-3000, United States
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date:
January 1999
Last updated: April 9, 2007
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