Combination Chemotherapy in Treating Patients With Myelodysplastic Syndrome

Leukemia Clinical Trial

Official title:

Treatment of Poor Risk Myelodysplasia With the Combination of Amifostine, Topotecan and ARA-C: A Phase II Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00003827
• Other study ID #: CDR0000066982
• Secondary ID: CHNMC-IRB-98056A
• Status: Active, not recruiting
• Phase: Phase 2
• First received: November 1, 1999
• Last updated: December 3, 2013
• Start date: January 1999

Study information

• Verified date: July 2007
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 25
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leukemia
• Myelodysplastic Syndromes
• Preleukemia
• Syndrome

Intervention

Drug:
• amifostine trihydrate

• cytarabine

• topotecan hydrochloride

Locations

Country	Name	City	State
United States	Cancer Center and Beckman Research Institute, City of Hope	Duarte	California

Sponsors (1)

Lead Sponsor	Collaborator
ALZA

Country where clinical trial is conducted

United States,