A Phase I Study of Salicylate for Adult Patients With Advanced Myelodysplastic Disorders or Acute Myelogenous Leukemia
sodium salicylate
Anémie+26
+ Anémie réfractaire
+ Maladies de la moelle osseuse
Étude thérapeutique
Résumé
Date de début de l'étude : 1 août 1999
Date à laquelle le premier participant a commencé l'étude.OBJECTIVES: Evaluate the safety, toxicity, and pharmacokinetics of sodium salicylate in patients with advanced myelodysplastic syndrome; newly diagnosed, relapsed, or refractory acute myelogenous leukemia; or relapsed or refractory chronic lymphocytic leukemia. Define biologic characteristics that influence the likelihood of a clinical response to this drug in this patient population. OUTLINE: Patients receive oral sodium salicylate twice a day. Intrapatient dose escalation or de-escalation is permitted. Treatment continues for up to 6 weeks in the absence of unacceptable toxicity or disease progression. Responding patients may continue to receive sodium salicylate beyond the 6-week period. Patients with acute myelogenous leukemia are followed until the end of therapy. Patients with myelodysplastic syndrome are followed until death or progression to leukemia. PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study within 1 year.
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.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 18 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: Relapsed or refractory acute myelogenous leukemia OR Elderly patients with newly diagnosed acute myelogenous leukemia not eligible for standard therapy OR "High-risk" myelodysplastic syndrome, including: Refractory anemia with excess blasts Refractory anemia with excess blasts in transformation Chronic myelomonocytic leukemia OR Relapsed or refractory chronic lymphocytic leukemia Not eligible for transplant protocols at MSKCC or refuses transplant Not eligible for a higher priority protocol (e.g., bone marrow transplantation) PATIENT CHARACTERISTICS: Age: Over 18 Performance status: Not specified Life expectancy: Not specified Hematopoietic: Platelet count at least 25,000/mm^3 Hepatic: Bilirubin no greater than 2.0 mg/dL Transaminase levels less than 3 times upper limit of normal PT no greater than 14 seconds PTT no greater than 34.6 seconds Renal: Creatinine no greater than 2.0 mg/dL OR Creatinine clearance greater than 60 mL/min Other: Not pregnant or nursing No history of abnormal bleeding or unexplained bleeding disorders No history of peptic ulcer disease No salicylate allergy No other concurrent active malignancy No other concurrent illness that would preclude study assessment to a significant degree PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified
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
Memorial Sloan-Kettering Cancer Center
New York, United StatesOuvrir Memorial Sloan-Kettering Cancer Center dans Google Maps