This trial is active, not recruiting.

Conditions leukemia, myelodysplastic syndromes
Treatments amifostine trihydrate, cytarabine, topotecan hydrochloride
Phase phase 2
Sponsor ALZA
Start date January 1999
Trial size 25 participants
Trial identifier NCT00003827, ALZA-CHNMC-IRB-98056, CDR0000066982, CHNMC-IRB-98056, NCI-V99-1533


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Primary purpose treatment

Eligibility Criteria

Male or female participants at least 16 years old.

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

Additional Information

Official title Treatment of Poor Risk Myelodysplasia With the Combination of Amifostine, Topotecan and ARA-C: A Phase II Study
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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2013.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).