Tandem High-Dose Chemotherapy With Autologous Stem Cell Rescue for Poor-Prognosis Germ Cell Cancer
filgrastim
+ carboplatin
+ etoposide
Maladies génito-urinaires+28
+ Maladies Génitales
+ Maladies Annexielles
Étude thérapeutique
Résumé
Date de début de l'étude : 1 février 1997
Date à laquelle le premier participant a commencé l'étude.OBJECTIVES: Estimate the antitumor activity of 2 courses of paclitaxel and carboplatin regimens with autologous stem cell rescue in patients with relapsed germ cell cancer. Evaluate the toxic effects of paclitaxel, carboplatin and etoposide (VP-16) with stem cell support followed by paclitaxel, carboplatin and ifosfamide with stem cell support in these patients. OUTLINE: Patients receive filgrastim (G-CSF) SC or IV 4 days prior to peripheral blood stem cells (PBSC) apheresis. Autologous bone marrow harvest is performed when adequate stem cells cannot be collected. Patients then receive course 1 of high-dose chemotherapy beginning on day -7 with paclitaxel IV over 24 hours. On days -6 to -4, patients receive etoposide IV over 2 hours and carboplatin (CBDCA) IV over 30 minutes 3 times daily. Following a 2 or 3 week recovery, a second course of chemotherapy begins on day -7, consisting of paclitaxel IV over 24 hours, then CBDCA and ifosfamide on days -6 to -4. Reinfusion of PBSC and marrow begins on day -2 in both course 1 and 2. In addition, G-CSF IV is given twice a day until 3 consecutive postnadir days of granulocytes of at least 1000/mm^3 are maintained. On day 0, stem cells with or without bone marrow product are again administered. Surgery may be performed after course 2 if indicated. PROJECTED ACCRUAL: The expected accrual rate is 12 patients per year 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.48 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 16 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: Evaluable germ cell cancer (measurable by radiographic study and/or serum tumor marker elevation) and not curable by standard salvage therapy OR viable cancer on resection of post-chemotherapy residual masses in either intermediate or high risk category Bidimensionally measurable disease with measurements performed within 21 days of study entry Tumor marker (alpha-fetoprotein, lactate dehydrogenase, beta-human chorionic gonadotropin) studies performed within 7 days prior to study entry PATIENT CHARACTERISTICS: Age: 16 and over Performance status: Karnofsky 70-100% Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 120,000/mm^3 Hemoglobin at least 10 g/dL Hepatic: Bilirubin no greater than 1.6 mg/dL SGOT and SGPT no greater than 2 times upper limit of normal (ULN) No active hepatitis or cirrhosis Renal: Creatinine clearance at least 70 mL/min Cardiovascular: Ejection fraction (MUGA or echocardiogram) normal No EKG evidence of active cardiac disease (arrhythmias, ischemia) which would contraindicate etoposide and paclitaxel study treatment Pulmonary: PaO_2 at least 70 mm Hg FEV_1 at least 2 L or 75% No history of bleomycin associated or serious lung disease Neurologic: No steroid or glucocorticoid treatment for patients with CNS metastatic disease; at least 1 month with stable post-radiotherapy neurological status and seizure free; if prior seizures, at least 1 month with therapeutic anticonvulsant levels prior to study Prior peripheral neuropathy requires consultation with principal investigator Other: No significant active medical illness precluding study or survival Not HIV positive No prior malignancy within past 5 years except for adequately treated basal cell or squamous cell skin cancer No prior hematologic malignancies PRIOR CONCURRENT THERAPY: Biologic therapy: No prior bone marrow or stem cell rescue with high-dose chemotherapy Chemotherapy: Prior chemotherapy allowed, excluding high-dose therapy with bone marrow or stem cell rescue No prior paclitaxel Endocrine therapy: Not specified Radiotherapy: No concurrent radiotherapy during study Surgery: Recovered from prior surgery
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
City of Hope Comprehensive Cancer Center
Duarte, United StatesOuvrir City of Hope Comprehensive Cancer Center dans Google Maps