Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Women With Metastatic Breast Cancer
A Phase II Study of Intensive-Dose Topotecan, Ifosfamide/Mesna and Etoposide (TIME) Followed by Autologous Stem Cell Rescue in Metastatic Breast Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by autologous peripheral stem cell transplantation in treating women who have metastatic breast cancer.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
OBJECTIVES: I. Evaluate the efficacy and toxicity of high dose topotecan with ifosfamide and etoposide followed by autologous peripheral blood stem cell rescue in women with metastatic breast cancer. II. Evaluate the response rates, progression free survival, engraftment, and nonrelapse related mortality in women treated with this regimen. III. Evaluate the pharmacokinetic profile of high dose topotecan with respect to the efficacy and toxicity of ifosfamide and etoposide in these women.
OUTLINE: Peripheral blood stem cells (PBSC) are harvested from the patient and stored. Patients receive ifosfamide IV over 2 hours and topotecan IV over 30 minutes on days -8 to -6, and etoposide IV daily over 24 hours on days -5 to -3. Autologous PBSC are reinfused on day 0. Patients are followed at 1, 3, 6, and 12 months, and then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study over 2 years.
Tipo de estudio
Fase
- Fase 2
Contactos y Ubicaciones
Ubicaciones de estudio
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Florida
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Tampa, Florida, Estados Unidos, 33612-9497
- H. Lee Moffitt Cancer Center and Research Institute
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
DISEASE CHARACTERISTICS: Histologically confirmed metastatic breast cancer that has demonstrated at least partial response to any salvage regimen Partial response defined as at least 50% reduction in measurable or evaluable disease for at least 4 weeks, no disease progression, no new lesions, or bone lesions that remain static for at least 8 weeks with an improvement in pain symptoms No more than 3 organs involved with metastatic disease No prior or active CNS involvement Hormone receptor status: Not specified
PATIENT CHARACTERISTICS: Age: 18 to 64 Sex: Female Menopausal status: Not specified Performance status: ECOG 0-1 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin no greater than 2.0 mg/dL SGOT or SGPT no greater than 2.5 times upper limit of normal No history of severe hepatic dysfunction Renal: Creatinine no greater than 2.0 mg/dL OR Creatinine clearance at least 60 mL/min Cardiovascular: No severe cardiac dysfunction Ejection fraction at least 50% by MUGA No major heart disease Controlled hypertension allowed Pulmonary: DLCO at least 50% of normal OR No symptomatic obstructive or restrictive disease Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective barrier contraception No uncontrolled insulin dependent diabetes mellitus No uncompensated major thyroid or adrenal dysfunction No significant skin breakdown from tumor or other disease No other prior malignancy in past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix No active infections HIV negative
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics No more than 2 prior salvage regimens for metastatic disease No prior topotecan Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified Other: No concurrent nitroglycerin preparations for angina No concurrent antiarrhythmics for major ventricular arrhythmias
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Silla de estudio: Karen K. Fields, MD, H. Lee Moffitt Cancer Center and Research Institute
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades de la piel
- Neoplasias
- Neoplasias por sitio
- Enfermedades de los senos
- Neoplasias de mama
- Mecanismos moleculares de acción farmacológica
- Inhibidores de enzimas
- Agentes antineoplásicos
- Agentes antineoplásicos, alquilantes
- Agentes alquilantes
- Agentes antineoplásicos, fitogénicos
- Inhibidores de la topoisomerasa II
- Inhibidores de la topoisomerasa
- Inhibidores de la topoisomerasa I
- Etopósido
- Ifosfamida
- Topotecán
Otros números de identificación del estudio
- MCC-12220
- MCC-IRB-5699
- NCI-G00-1809
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