Completado

Phase II Study of Intensive Carmustine and Etoposide With Cisplatin or Cyclophosphamide, Followed By Rescue With Autologous Bone Marrow Treated In Vitro With Etoposide and/or Peripheral Blood Stem Cells Mobilized With Filgrastim (G-CSF) or Sargramostim (GM-CSF) With or Without Radiotherapy in Patients With Resistant Hodgkin's Disease or Non-Hodgkin's Lymphoma

0 criterios cumplidosConsulta de un vistazo cómo tu perfil cumple con cada criterio de elegibilidad.
Qué se está evaluando

filgrastim

+ sargramostim

+ carmustine

BiológicoMedicamentoProcedimientoRadiación
Quiénes están siendo reclutados

Enfermedad Crónica+22

+ Infecciones por virus ADN

+ Enfermedades Hematológicas

De 15 a 65 años
Ver todos los criterios de elegibilidad
Cómo está diseñado el estudio

Estudio de Tratamiento

Fase 2
Intervencional
Inicio del estudio: abril de 1988
Ver detalles del protocolo

Resumen

Patrocinador PrincipalMontefiore Medical Center
Última actualización: 17 de agosto de 2018
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Fecha de inicio: 1 de abril de 1988

Fecha en la que se inscribió al primer participante.

OBJECTIVES: I. Determine the antitumor activity of intensive carmustine and etoposide with cisplatin or cyclophosphamide, followed by rescue with autologous bone marrow (ABM) treated in vitro with etoposide and/or peripheral blood stem cells mobilized with filgrastim (G-CSF) or sargramostim (GM-CSF) with or without radiotherapy in patients with refractory Hodgkin's disease or non-Hodgkin's lymphoma. II. Determine the time to recovery of peripheral blood counts in patients treated with this regimen. III. Correlate the rate of peripheral blood cell recovery in these patients with in vitro growth of ABM treated with etoposide. OUTLINE: This is a multicenter study. Autologous bone marrow (ABM) is harvested and two-thirds of the ABM is treated in vitro with etoposide (VP-16). ABM may have been stored earlier in the course of the disease for patients who are at high risk of relapse or who were previously treated with agents causing bone marrow or stem cell damage (e.g., nitrosoureas, pelvic irradiation). Patients with prior bone marrow involvement and subsequent bone marrow remission must have received 1 or 2 additional courses of the same chemotherapy before undergoing harvest of ABM. Patients for whom PBSC rescue alone is planned also undergo ABM harvest in case back-up ABM rescue is needed. Patients then receive sargramostim (GM-CSF) or filgrastim (G-CSF) subcutaneously beginning 5 days before harvest of peripheral blood stem cells (PBSC) and continuing until completion of harvest. Patients without extensive prior radiotherapy undergo radiotherapy to areas of measurable active disease plus a 2 cm margin on days -21 to -17 and -14 to -8. Patients without a contraindication to cisplatin (e.g., hearing impairment, peripheral neuropathy) receive cisplatin IV over 3 hours on days -7 to -3 and carmustine IV over 2 hours and VP-16 IV over 4 hours on days -6 to -4. Patients with a contraindication to cisplatin receive cyclophosphamide IV every 12 hours, VP-16 IV over 1 hour every 12 hours, and carmustine IV over 1 hour on days -7 to -4. ABM and/or PBSC are reinfused on day 0. The first 6 ABM rescue patients receive untreated ABM and subsequent patients receive ABM treated in vitro with VP-16. Patients with bone marrow biopsy showing no evidence of regeneration (marrow cellularity less than 1%) at day 21 after PBSC rescue undergo back-up ABM rescue. Patients without engraftment (granulocyte count less than 500/mm3 and untransfused platelets no greater than 20,000/mm3) by day 28 after rescue with ABM treated in vitro with VP-16 undergo rescue with untreated ABM. PROJECTED ACCRUAL: A total of 21-46 patients will be accrued for this study.

NCT00002461
Patrocinador PrincipalMontefiore Medical Center
Última actualización: 17 de agosto de 2018
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Protocolo

Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.
Detalles del Diseño

Se reclutarán 35 pacientes

Número total de participantes que el ensayo clínico espera reclutar.

Estudio de Tratamiento

Estos estudios prueban nuevas formas de tratar una enfermedad, condición o problema de salud. El objetivo es determinar si un nuevo medicamento, terapia o enfoque funciona mejor o tiene menos efectos secundarios que las opciones existentes.

Elegibilidad

Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.
Condiciones
Criterios

Cualquier sexo

Sexo biológico de los participantes elegibles para inscribirse.

De 15 a 65 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

Enfermedad CrónicaInfecciones por virus ADNEnfermedades HematológicasEnfermedades hemáticas y linfáticasInfecciones por HerpesviridaeEnfermedades del sistema inmunitarioTrastornos InmunoproliferativosInfeccionesLeucemiaLeucemia LinfocíticaEnfermedades LinfáticasTrastornos LinfoproliferativosNeoplasiasNeoplasias por tipo histológicoProcesos PatológicosCondiciones Patológicas, Signos y SíntomasInfecciones por Virus TumoralesEnfermedades ViralesLeucemia de células BLinfoma de BurkittEnfermedad de HodgkinLinfomaLinfoma FolicularLinfoma no HodgkinLeucemia linfocítica crónica de células B

Criterios

DISEASE CHARACTERISTICS: Diagnosis of resistant Hodgkin's disease Eligible subtypes: Lymphocytic predominance Nodular sclerosing Mixed cellularity Lymphocyte depleted Not otherwise specified Must meet 1 of the following conditions: Disease progression after at least 1 course of prior therapy on each of 2 regimens comprising combination chemotherapy or radiotherapy Less than a partial remission (PR) after at least 2 courses on each of 2 regimens Failure to achieve a complete remission (CR) after 6 courses of 1 or 2 regimens Relapse less than 1 year off initial therapy OR Diagnosis of intermediate- or high-grade non-Hodgkin's lymphoma (NHL) Eligible subtypes: Diffuse poorly differentiated lymphocytic Diffuse mixed lymphocytic-histiocytic Nodular histiocytic Diffuse histiocytic Diffuse undifferentiated Lymphoblastic Must meet 1 of the following conditions: Disease progression after 1 course of prior therapy Failure to achieve a PR after 2 courses of prior therapy Failure to achieve a CR after 6 courses of prior therapy OR Diagnosis of low-grade NHL Eligible subtypes: Diffuse well-differentiated lymphocytic Nodular poorly differentiated lymphocytic Nodular mixed lymphocytic-histiocytic Failure on second-line therapy administered for progressive symptomatic disease or organ compromise Measurable disease by physical exam, external imaging or scanning studies, or tumor markers No severe symptomatic CNS disease of any etiology History of prior CNS tumor allowed if no signs or symptoms at study entry Active CNS lymphoma (meningeal lymphomatosis) rendered disease-free by conventional therapies allowed Epidural metastases or discrete parenchymal brain lesions allowed if tumors can be encompassed in standard treatment fields Bilateral marrow core biopsy free of tumor and showing at least 30% cellularity Prior marrow involvement allowed if marrow is histologically normal at time of storage No significant skin breakdown due to tumor or other disease A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology. PATIENT CHARACTERISTICS: Age: 15 to 65 Performance status: Karnofsky 70-100% OR ECOG 0-1 Life expectancy: At least 8 weeks without transplantation Hematopoietic: Granulocyte count at least 1,500/mm3 Platelet count at least 150,000/mm3 Hepatic: Bilirubin no greater than 1.8 mg/dL SGOT and SGPT less than 2 times normal No high risk for veno-occlusive disease of the liver Renal: No severe renal dysfunction unless due to tumor invasion Creatinine no more than 1.5 mg/dL Creatinine at least 60 mL/min Cardiovascular: No severe cardiovascular dysfunction unless due to tumor invasion No myocardial infarction within the past 6 months No symptoms of major heart disease Ejection fraction at least 50% by MUGA scan Essential hypertension controlled with medication allowed Pulmonary: No severe pulmonary dysfunction unless due to tumor invasion DLCO at least 50% normal No symptomatic obstructive or restrictive pulmonary disease Other: No insulin-dependent diabetes mellitus No uncompensated major thyroid or adrenal dysfunction No active infection HTLV-III negative (no AIDS-related complex) PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics At least 4 weeks since prior chemotherapy (at least 6 weeks since prior nitrosoureas or mitomycin) Prior exposure to etoposide, cisplatin, or carmustine allowed if cumulative dose of chloroethylnitrosourea (carmustine or lomustine) no greater than 400 mg/m2 Prior doxorubicin or daunorubicin dose of 450 mg/m2 or more allowed if LVEF at least 50% No concurrent chemotherapy Endocrine therapy: Concurrent corticosteroids for hypercalcemia allowed Radiotherapy: See Disease Characteristics No prior whole-pelvic radiotherapy Other prior radiotherapy allowed Surgery: Not specified Other: No concurrent nitroglycerin preparations for angina pectoris No concurrent antiarrhythmic drugs for major ventricular arrhythmias

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

Albert Einstein Comprehensive Cancer Center

The Bronx, United StatesAbrir Albert Einstein Comprehensive Cancer Center en Google Maps
Completado1 Centros de Estudio