Phase II Study of High Dose Cyclophosphamide, Mitoxantrone, and Carboplatin With Autologous Bone Marrow Transplantation in Refractory or Relapsed Ovarian Carcinoma
carboplatin
+ cyclophosphamide
+ mitoxantrone hydrochloride
Enfermedades Urogenitales+15
+ Enfermedades Genitales
+ Enfermedades Anexiales
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de febrero de 1991
Fecha en la que se inscribió al primer participante.OBJECTIVES: Determine the response rate, duration of response, and overall survival of patients with refractory or relapsed ovarian epithelial cancer treated with high-dose cyclophosphamide, carboplatin, and mitoxantrone followed by autologous bone marrow transplantation. Determine the nonhematopoietic toxicity of this regimen in these patients. OUTLINE: Autologous bone marrow is harvested before study entry. Patients receive high-dose cyclophosphamide IV over 1 hour and mitoxantrone IV over 15 minutes on days -8, -6, and -4 and carboplatin IV continuously on days -8 to -3 in the absence of unacceptable toxicity. Bone marrow is reinfused on day 0 beginning at least 60 hours after completion of carboplatin infusion. Patients are followed for survival. PROJECTED ACCRUAL: A total of 15-30 patients will be accrued for this study within 1.5-3 years.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Estudio de Tratamiento
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Mujer
Sexo biológico de los participantes elegibles para inscribirse.Hasta 64 Años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos no permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
DISEASE CHARACTERISTICS: Diagnosis of refractory or relapsed ovarian epithelial cancer Must have failed prior regimen containing cisplatin or carboplatin Bidimensionally measurable or evaluable disease Serial CA-125 antigen titers or cytologically positive pleural effusion and/or ascites acceptable as evaluable disease Autologous bone marrow harvest of greater than 1.2 x 10 to the eighth nucleated cells/kg required before study entry No evidence of tumor at marrow harvest sites by bilateral bone marrow aspirates and biopsies, pelvic x-ray, and bone scan CNS involvement allowed PATIENT CHARACTERISTICS: Age: Under 65 Performance status: SWOG 0-2 Life expectancy: At least 8 weeks Hematopoietic: WBC greater than 3,500/mm^3 Platelet count greater than 100,000/mm^3 Hemoglobin greater than 10.0 g/dL Hepatic: Bilirubin less than 2.0 mg/dL SGOT and SGPT less than 2 times upper limit of normal Renal: Creatinine clearance greater than 60 mL/min No prior hemorrhagic cystitis Cardiovascular: LVEF greater than 45% by MUGA scan Other: No hearing loss in voice tones No active infection No psychological contraindication to study treatment Not pregnant Negative pregnancy test HIV negative General medical condition must allow general anesthesia PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics No prior bone marrow transplantation More than 4 weeks since other prior biologic therapy and recovered Chemotherapy: See Disease Characteristics More than 4 weeks since prior chemotherapy (at least 6 weeks for nitrosoureas or mitomycin) and recovered Endocrine therapy: Not specified Radiotherapy: More than 4 weeks since prior radiotherapy and recovered Surgery: Not specified
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.Objetivos del Estudio
Objetivos Primarios
Centros del Estudio
Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.Este estudio tiene una ubicación
Cardinal Bernardin Cancer Center at Loyola University Medical Center
Maywood, United StatesAbrir Cardinal Bernardin Cancer Center at Loyola University Medical Center en Google Maps