Clinical trial · Interventional
Combination Chemotherapy in Treating Patients With Myelodysplastic Syndrome
Treatment of Poor Risk Myelodysplasia With the Combination of Amifostine, Topotecan and ARA-C: A Phase II Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
| Myelodysplastic Syndromes | Myelodysplastic Syndrome | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| amifostine trihydrate | Drug | — | UNRESOLVED |
| cytarabine | Drug | Cytarabine | ALIAS |
| topotecan hydrochloride | Drug | Topotecan | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available