A Phase II Study Evaluating the Efficacy of Gemcitabine, Carboplatin, and Dexamethasone and Rituximab for Previously Treated Lymphoid Malignancies
gemcitabine hydrochloride
+ carboplatin
+ dexamethasone
Lymphome plasmoblastique+56
+ Adénopathie
+ Infections bactériennes et mycoses
Étude thérapeutique
Résumé
Date de début de l'étude : 1 août 2003
Date à laquelle le premier participant a commencé l'étude.OBJECTIVES: I. To determine the feasibility and safety of Gemcitabine/Carboplatin/Dexamethasone with or without Rituximab in previously treated lymphoid malignancies (rituximab will only be evaluated in CD20 positive malignancies). II. To determine the efficacy of the above regimen. III. To determine the ability to proceed to blood stem peripheral blood collection following the above regimens (the impact of above regimen on stem cell reserve). IV. To determine remission duration. All patients are treated with gemcitbine, carboplatin, and dexamethasone. Patients with CD20 + lymphomas also receive rituximab. After completion of study treatment, patients are followed up at 3-4 weeks and then every 6 months for 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.55 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 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
Inclusion Criteria: * Patients must have relapsed or primary refractory lymphoid malignancy (including B-cell, T-cell, or Hodgkin's Disease) * Revised European American classification (REAL), or World Health Organization (WHO) classification of patients malignancies must be provided * Patients must have measurable disease defined as lesions that can be accurately measured in two dimensions by computed tomography (CT), magnetic resonance imaging (MRI), medical photograph (skin or oral lesion), plain x-ray, or other conventional technique and a greatest transverse diameter of 1 cm or greater; or palpable lesions with both diameters \>= 2 cm; Note: CT scans remain the standard for evaluation of nodal disease * Patients must have a bone marrow aspirate and biopsy within 28 days of enrollment and no intervening anticancer therapy * Patients must have a CT of chest, abdomen, and pelvis within 28 days of enrollment; patients with evidence of adenopathy in the neck must have a CT of neck * Patients should not have evidence active central nervous system lymphoma * Patients must have a Southwest Oncology Group (SWOG) performance status of 0, 1, or 2 * Patients should have absolute neutrophil count (ANC) \>= 1,500/uL; exception: patients with cytopenia thought to be due to disease in their bone marrow, that do not meet this criteria, may be enrolled on the protocol at the Study Chair's discretion * Patients should have platelets \>= 100,000/uL; exception: patients with cytopenia thought to be due to disease in their bone marrow, that do not meet this criteria, may be enrolled on the protocol at the Study Chair's discretion * Serum bilirubin less than 2 times the upper limit of normal * Serum creatinine less than 1.5 times the upper limit of normal and creatinine clearance greater than 50/ mL per minute * Patients must have serum lactate dehydrogenase (LDH) performed within 14 days prior to treatment * All patients must be informed of the investigational nature of this study and have given written consent in accordance with institutional and federal guidelines * Must anticipate that patient will complete at least 2 cycles of chemotherapy Exclusion Criteria: * Patients known to be human immunodeficiency virus (HIV) positive * Pregnant or nursing women; men or women of reproductive potential may not participate unless they have agreed to use an effective contraceptive method * Patients with other prior malignancies except for adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, cervical cancer in situ, or other cancer from which the patient has been disease-free for 5 years or greater unless approved by the Principal Investigator (PI) * Patients that are refractory (i.e., not responded or progressed within 6 months) to a carboplatin or cisplatin-based regimen or a gemcitabine-based regimen * Patients with active hepatitis B virus (HBV) infection or hepatitis * Patients that have other medical conditions that would contraindicate treatment with aggressive chemotherapy
Plan de l'étude
Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.Un seul groupe d'intervention est désigné dans cette étude
Cette étude ne comporte pas de groupe placebo.
Groupes de traitement
Groupe I
ExpérimentalObjectifs de l'étude
Objectifs principaux
Objectifs secondaires
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
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, United StatesVoir le site