A Pilot Study of Peripheral Blood Stem Cell Transplantation (PBSCT) After Preparative Therapy Consisting of Cyclophosphamide, BCNU, and Etoposide (CBV) for Recurrent and Primarily Refractory Hodgkin's and Non-Hodgkin's Lymphoma
carmustine
+ cyclophosphamide
+ etoposide
Infections par virus ADN+22
+ Maladies hématologiques et lymphatiques
+ Infections à Herpèsviridae
Étude thérapeutique
Résumé
Date de début de l'étude : 1 avril 1998
Date à laquelle le premier participant a commencé l'étude.OBJECTIVES: Estimate the failure-free survival rate in a cohort of relapsed Hodgkin's lymphoma and non-Hodgkin's lymphoma patients after retrieval therapy which includes peripheral blood stem cell transplantation (PBSCT) in patients who achieve a complete remission or partial remission. Estimate the post complete/partial remission failure-free survival rate in these patients. Characterize the time to recovery of normal bone marrow function after transplantation in these patients. OUTLINE: Patients receive 2 courses of reinduction chemotherapy followed by bone marrow biopsy and aspirate prior to peripheral blood stem cell (PBSC) harvest. If marrow involvement is still present at harvest, then 2 additional courses of induction chemotherapy are given. The PBSC transplantation preparative regimen should begin within 2 weeks of completing reinduction therapy course, consisting of the following: Carmustine IV over 3 hours on days -8, -7, and -6 Etoposide continuous IV over days -8, -7, and -6 Cyclophosphamide IV over 1 hour daily on days -5, -4, -3, and -2 Mesna as a 15 min infusion before each dose of cyclophosphamide then at 3, 6, 9, and 12 hours after initiation of each cyclophosphamide dose Methylprednisolone IV is given to protect lungs from the toxic effects of carmustine. PROJECTED ACCRUAL: A total of 30 patients will be accrued in each subgroup.
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.69 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 1 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: Histologically confirmed non-Hodgkin's lymphoma in first relapse or refractory after primary induction therapy Histologically confirmed Hodgkin's lymphoma in first relapse after chemotherapy with more than one nodal region involved at relapse or refractory after primary induction therapy (i.e., failed to achieve remission at the conclusion of standard induction chemotherapy) No prior radiotherapy only for low stage nodal disease No greater than 4 courses of standard chemotherapy for low stage nodal disease CSF or bone marrow involvement at time of study entry is allowed PATIENT CHARACTERISTICS: Age: 1 to 21 (at initial diagnosis) Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: SGOT or SGPT less than 2.5 times normal Bilirubin no greater than 1.5 mg/dL Renal: Creatinine less than 1.5 mg/dL Glomerular filtration rate greater than 60 mL/min as measured by radionuclide scan or 24 hour urine collection for creatinine clearance Cardiovascular: Shortening fraction of at least 28% by echocardiogram Ejection fraction of at least 40% by radionuclide angiogram echocardiogram Pulmonary: Total lung capacity (TLC) at least 50% OR Vital capacity (VC) at least 65% of normal DLCO at least 55% of normal For children who are uncooperative to pulmonary function testing, no dyspnea at rest or with mild exercise, and a pulse oximetry of at least 95% Other: HIV negative PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics Surgery: Not specified
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 235 sites
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, United StatesOuvrir University of Alabama at Birmingham Comprehensive Cancer Center dans Google MapsUniversity of South Alabama Medical Center
Mobile, United StatesPhoenix Children's Hospital
Phoenix, United StatesArizona Cancer Center
Tucson, United States