A Phase II Study to Evaluate Safety and Efficacy of Specific Immunotherapy, Recombinant Idiotype Conjugated to KLH and GM-CSF Following the Anti-CD20 Antibody, Rituximab, in Previously Treated Patients With Follicular Non-Hodgkin's Lymphoma
Colección de datos
Enfermedades del sistema inmunitario+5
+ Trastornos Inmunoproliferativos
+ Enfermedades Linfáticas
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de marzo de 2003
Fecha en la que se inscribió al primer participante.OBJECTIVES: * Determine progression-free survival in patients with refractory or progressive follicular non-Hodgkin's lymphoma treated with immediate or delayed autologous immunoglobulin idiotype-KLH conjugate vaccine and sargramostim after rituximab (groups I and II). * Determine the immune response rate in patients treated with these regimens (groups I, II, and III). * Determine the safety and toxicity of these regimens in these patients (groups I, II, and III). OUTLINE: This is an open-label, multicenter study for patients previously registered on and confirmed ineligible for randomization in protocol Genitope-G2000-03. Patients receive rituximab IV weekly for 4 weeks. * Group I: The first 30 patients to achieve and maintain a partial response (PR) or better receive autologous immunoglobulin idiotype-KLH conjugate vaccine subcutaneously (SC) on day 1 and sargramostim SC on days 1-4 beginning 26 weeks after the last dose of rituximab. Treatment repeats every 2 weeks for 14 weeks (8 immunizations). * Group II: All subsequent patients who achieve a PR or better receive autologous immunoglobulin idiotype-KLH conjugate vaccine and sargramostim SC as in group I beginning 13 weeks after the last dose of rituximab. * Group III: Patients who are not eligible for group I or II and, in the investigator's opinion, are suitable candidates for immunization with autologous immunoglobulin idiotype-KLH conjugate vaccine and sargramostim SC receive the same treatment as groups I and II, beginning no more than 1 year after the last (fourth) dose of rituximab. In all groups, treatment continues in the absence of unacceptable toxicity or emergence of an illness that may interfere with study assessments. Patients are followed for initial response 8 weeks after completion of immunizations and then every 12 weeks for an additional year. Thereafter, all immunized patients will be followed every 6 months until receipt of first subsequent anti-lymphoma therapy. PROJECTED ACCRUAL: Up to 120 patients will be accrued for this study.
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.Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.A partir de 18 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: * Histologically confirmed follicular center cell non-Hodgkin's lymphoma * Stage III or IV disease at time of entry on Genitope-G2000-03 * At least 1 bidimensionally measurable lesion (1.5 cm X 1.5 cm) by radiography * Previously registered on and confirmed to be ineligible for randomization on Genitope-G2000-03 by failing to achieve or maintain a complete or partial response after chemotherapy by CT scans of the chest, abdomen, and pelvis (and neck if there was palpable disease) * Completed all 8 courses of chemotherapy (cyclophosphamide, vincristine, and prednisone \[CVP\]) per Genitope-G2000-03 * No intervening therapy for lymphoma (i.e., antibody, corticosteroids, or cytotoxic) between CVP and study entry * No evidence of transformation (e.g., rapid tumor growth or increasing lactic dehydrogenase) * No CNS involvement PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-1 Life expectancy * Not specified Hematopoietic * Not specified Hepatic * Not specified Renal * Not specified Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 6 months after the last immunization series * HIV negative * No history of autoimmune disease or conditions requiring treatment with immunosuppressive agents, including corticosteroids * No other malignancy within the past 2 years except non-basal cell skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy * See Disease Characteristics Chemotherapy * See Disease Characteristics Endocrine therapy * See Disease Characteristics * At least 6 months since prior corticosteroids, including topical administration for any concurrent disease * No concurrent chronic (more than twice monthly) corticosteroids (including topical or inhaled) * Transient use (prior to CT scan) or optical solutions allowed Radiotherapy * Prior radiotherapy to no more than 2 sites more than 13 weeks before rituximab is allowed Surgery * Not specified Other * No concurrent participation in other therapeutic clinical trials
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.Objetivos del Estudio
Objetivos Primarios
Objetivos Secundarios
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 11 ubicaciones
Rush Cancer Institute at Rush University Medical Center
Chicago, United StatesIndiana University Cancer Center
Indianapolis, United StatesSidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, United States