High-Dose Thiotepa With Autologous Stem Cell Rescue in Patients With Malignancies Refractory to Conventional Chemotherapy
filgrastim
+ thiotepa
+ autologous bone marrow transplantation
Maladies génito-urinaires+33
+ Maladies Génitales
+ Maladies Annexielles
Étude thérapeutique
Résumé
Date de début de l'étude : 1 septembre 1997
Date à laquelle le premier participant a commencé l'étude.OBJECTIVES: Evaluate the efficacy and toxicity of sequential cycles of high dose thiotepa with stem cell rescue and filgrastim in patients with malignancies refractory to conventional chemotherapy or for whom conventional therapy is not available. Evaluate the effectiveness of autologous stem cells in restoring hematopoiesis following high dose thiotepa. OUTLINE: Patients are stratified by type of tumor (neuroectodermal CNS tumor vs non-neuroectodermal CNS tumor vs non-CNS small round blue cell tumor vs other non-CNS tumor). Autologous stem cells are obtained prior to the administration of thiotepa. Patients who do not have peripheral blood stem cells available may undergo a bone marrow harvest instead. Thiotepa is administered as a 3 hour infusion daily for 3 consecutive days. Stem cells are reinfused approximately 72 hours following the completion of thiotepa. Filgrastim is administered the day following reinfusion of stem cells and continues until there is sufficient hematopoietic recovery. The second course of thiotepa is administered 4 weeks following the first course in patients who have responding or stable disease, adequate stem cells, and no unacceptable toxicity. Patients receive a maximum of 2 courses. PROJECTED ACCRUAL: Approximately 36 patients will be accrued for this study over 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.36 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.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: Malignant solid tumors Must have failed conventional treatment or for whom conventional therapy is not available Measurable disease by MRI or CT scan Intraocular retinoblastomas may be measured by direct visualization Germ cell tumors may be measured by tumor markers No known bone marrow involvement PATIENT CHARACTERISTICS: Age: Any age Performance status: Lansky 60-100% for patients 16 and under Karnofsky 60-100% for patients over 16 Life expectancy: At least 8 weeks Hematopoietic: Absolute neutrophil count at least 1,000/mm^3 Platelet count at least 75,000/mm^3 If parameters not met, must have adequate stem cell yield Hepatic: Bilirubin no greater than 1.5 times the upper limit of normal (ULN) SGOT and SGPT no greater than 2.5 times the ULN (unless liver involvement by tumor) Renal: Creatinine within normal limits OR Creatinine clearance at least 70 mL/min Cardiovascular: Fractional shortening greater than 28% on echocardiogram OR Ejection fraction at least 55% on RNCA prior to first cycle of thiotepa Pulmonary: DLCO greater than 55% of predicted (only required if there is clinical evidence of pulmonary dysfunction) Other: Not pregnant or nursing Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: Prior bone marrow or peripheral blood stem cell rescue allowed Chemotherapy: At least 4 weeks since prior chemotherapy if absolute neutrophil count is less than 1,000/mm^3 or platelet count is less than 75,000/mm^3, and recovered (i.e. adequate stem cells collected to predict hematopoietic recovery) No concurrent chemotherapy except for dexamethasone for antiedema effects Endocrine therapy: No concurrent use of corticosteroids used solely as antiemetics Radiotherapy: At least 4 weeks since radiotherapy if absolute neutrophil count is less than 1,000/mm^3 or platelet count is less than 75,000/mm^3, and recovered (i.e. adequate stem cells collected to predict hematopoietic recovery) 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 2 sites
NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York, United StatesOuvrir NYU School of Medicine's Kaplan Comprehensive Cancer Center dans Google MapsMemorial Sloan-Kettering Cancer Center
New York, United States