Treatment of Poor Risk Myelodysplasia With the Combination of Amifostine, Topotecan and ARA-C: A Phase II Study
amifostine trihydrate
+ cytarabine
+ topotecan hydrochloride
Anémie+7
+ Anémie réfractaire
+ Maladies de la moelle osseuse
Étude thérapeutique
Résumé
Date de début de l'étude : 1 janvier 1999
Date à laquelle le premier participant a commencé l'étude.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.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.25 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Traitement
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.À partir de 16 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
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
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 1 site
Cancer Center and Beckman Research Institute, City of Hope
Duarte, United StatesOuvrir Cancer Center and Beckman Research Institute, City of Hope dans Google Maps