Phase II Trial of Trimetrexate and Leucovorin in The Treatment of Recurrent Childhood Acute Lymphoblastic Leukemia
leucovorin calcium
+ trimetrexate glucuronate
Infections par virus ADN+26
+ Maladies Hématologiques
+ Maladies hématologiques et lymphatiques
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 efficacy of trimetrexate glucuronate with leucovorin calcium rescue in children with recurrent acute lymphoblastic leukemia, recurrent osteogenic sarcoma, or refractory non-Hodgkin's lymphoma resistant to methotrexate. Evaluate the toxicity of this treatment regimen in this patient population. OUTLINE: Patients are stratified according to disease (acute lymphocytic leukemia, non-Hodgkin's lymphoma vs osteogenic sarcoma). Patients receive trimetrexate glucuronate orally or IV every 12 hours on days 1-21 and oral leucovorin calcium every 12 hours on days 1-24. Treatment repeats every 4 weeks. Patients with stable or responsive disease may receive up to 4 courses of therapy. PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study within 2 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.Jusqu'à 21 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: Histologic evidence of one of the following malignancies that has failed conventional therapy: Acute lymphoblastic leukemia Non-Hodgkin's lymphoma with bone marrow involvement Osteogenic sarcoma In vitro transport resistance to methotrexate demonstrated by bone marrow aspirate assay PATIENT CHARACTERISTICS: Age: 21 and under at diagnosis Performance status: ECOG 0-2 Life expectancy: At least 8 weeks Hematopoietic: Granulocytopenia allowed with bone marrow involvement Thrombocytopenia allowed with bone marrow involvement Anemia allowed with bone marrow involvement Hepatic: (unless due to disease) Bilirubin no greater than 2.0 mg/dL AST no greater than 100 Renal: Creatinine less than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min Other: No other serious medical illness Not pregnant or nursing Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: Prior bone marrow transplantation allowed Chemotherapy: At least 1 week since prior intrathecal treatment At least 2 weeks since prior systemic chemotherapy and recovered At least 10 days for rapidly proliferating leukemia (i.e., WBC greater than 50,000) No concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: Prior radiotherapy allowed and recovered No concurrent 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
Memorial Sloan-Kettering Cancer Center
New York, United StatesOuvrir Memorial Sloan-Kettering Cancer Center dans Google Maps