A PHASE I TRIAL OF SUBCUTANEOUS, OUTPATIENT INTERLEUKIN-2 FOR PATIENTS WITH MYELODYSPLASTIC SYNDROME (MDS)
aldesleukin
Anémie+16
+ Maladies de la moelle osseuse
+ Maladie chronique
Étude thérapeutique
Résumé
Date de début de l'étude : 1 janvier 1996
Date à laquelle le premier participant a commencé l'étude.OBJECTIVES: Determine the safety, tolerance, and maximum tolerated dose of subcutaneous interleukin-2 (aldesleukin; IL-2) in patients with myelodysplastic syndrome (MDS). Evaluate the hematologic effects of subcutaneous IL-2 in MDS. OUTLINE: IL-2 will be administered in cycles of twice daily subcutaneous injections 7 days a week for 4 consecutive weeks. After each cycle the patient will be evaluated for response. The patient could continue IL-2 therapy for up to 12 cycles. There are 4 dose levels of IL-2. At each dose level 3 patients will be accrued sequentially. Treatment with IL-2 should be continued until grade III toxicity or any side effects requiring hospitalization occurs. After the patient returns to baseline pretherapy values or grade I toxicity, the subject will resume IL-2 at 50% of the initial dose. If the patient again goes into grade III toxicity or is in need of hospitalization, IL-2 will be discontinued. PROJECTED ACCRUAL: Between 12-24 patients will be accrued.
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.24 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.De 15 à 120 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 myelodysplastic syndrome: Refractory anemia (RA), refractory anemia with ringed sideroblasts (RARS), refractory anemia with excess blasts (RAEB) or chronic myelomonocytic leukemia (CMML) No patients with refractory anemia with excess blasts in transformation (RAEB-t) PATIENT CHARACTERISTICS: Age: 15 and over Performance status: Karnofsky 70-100 Hematopoietic: Platelet count greater than 20,000 Hepatic: Bilirubin less than 1.6 mg/dL SGOT less than 150 U/L Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No symptoms of coronary artery disease, congestive heart failure, edema, clinically manifest hypotension, presence of cardiac arrhythmias on EKG, or severe hypertension Pulmonary: No significant pleural effusion, dyspnea at rest or severe exertional dyspnea Other: No patients with nephrotic syndrome No uncontrolled infections or active peptic ulcer disease No serious intercurrent medical illness Not pregnant or nursing Adequate contraception required of all patients PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior immunosuppressive therapy Chemotherapy: At least 4 weeks since prior chemotherapy Endocrine therapy: At least 2 weeks since corticosteroid therapy At least 4 weeks since other endocrine therapy Radiotherapy: At least 4 weeks since prior radiotherapy 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
University of Washington Medical Center
Seattle, United StatesOuvrir University of Washington Medical Center dans Google Maps