Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Combination Chemotherapy in Treating Patients With Myelodysplastic Syndrome

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Supportive care, Treatment	Closed	16 and over	Pharmaceutical / Industry	CHNMC-IRB-98056 ALZA-CHNMC-IRB-98056, NCI-V99-1533, NCT00003827

Objectives

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

Entry 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%)

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

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

Expected Enrollment

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

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.

Trial Contact Information

Trial Lead Organizations

ALZA Corporation

Henry Fung, MD, FRCPE, Protocol chair(Contact information may not be current)		Ph: 626-359-8111; 1-800-826-4673 ext. 2405 Email: hfung@smptlink.coh.org

Registry Information
Official Title		Treatment of Poor Risk Myelodysplasia with the Combination of Amifostine, Topotecan and ARA-C: A Phase II Study
Trial Start Date		1999-01-29
Registered in ClinicalTrials.gov		NCT00003827
Date Submitted to PDQ		1999-03-24
Information Last Verified		2007-07-12

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