- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00134082
Rituximab and Cyclophosphamide Followed by Vaccine Therapy in Treating Patients With Relapsed Hodgkin Lymphoma
Pilot Study of Rituximab, High Dose Cyclophosphamide, and GM-CSF Based Immunotherapy for Relapsed Hodgkin's Lymphoma
RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of cancer cells either by killing the cells or by stopping them from dividing. Vaccines made from another person's cancer cells may help the body build an effective immune response to kill cancer cells. Giving rituximab together with chemotherapy and vaccine therapy may kill more cancer cells
PURPOSE: This phase I/II trial is studying how well giving rituximab together with cyclophosphamide and vaccine therapy works in treating patients with relapsed Hodgkin lymphoma.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
OBJECTIVES:
Primary
- Determine the safety and tolerability of rituximab and high-dose cyclophosphamide followed by vaccine therapy comprising an allogeneic vaccine that expresses Hodgkin's tumor antigens and sargramostim (GM-CSF) (KGEL vaccine) as salvage therapy in patients with relapsed Hodgkin lymphoma.
- Determine the immunologic response to this vaccine in these patients.
Secondary
- Determine the 3-year relapse-free and overall survival of patients treated with this regimen.
- Determine the patterns of cellular immune reconstitution in patients treated with this regimen.
OUTLINE: This is an open-label study.
Patients receive rituximab IV on days -10 and -7 and then on days 29, 36, 43, and 50 (weeks 4-7) and high-dose (transplant-dose) cyclophosphamide IV on days -3 to 0 without stem cell rescue. Patients receive filgrastim (G-CSF) subcutaneously once daily beginning on day 6 and continuing until blood counts recover. Patients also receive vaccine therapy comprising an allogeneic vaccine that expresses Hodgkin's tumor antigens and sargramostim (GM-CSF) (KGEL vaccine) intradermally on day 1, and weeks 4, 8, 12, 16, and 24.
After completion of high-dose cyclophosphamide, patients are followed every 3 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: Approximately 25 patients will be accrued for this study.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 2
- Fase 1
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Maryland
-
Baltimore, Maryland, Estados Unidos, 21231-2410
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
DISEASE CHARACTERISTICS:
- Histologically confirmed classical Hodgkin's lymphoma
Relapsed disease with achievement of at least a partial response or a metabolic response to most recent salvage therapy
- No primary induction failure, defined as disease progression during or within 2 months after completion of first-line therapy
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-1
Life expectancy
- Not specified
Hematopoietic
- Absolute neutrophil count ≥ 1,000/mm^3
- Platelet count ≥ 75,000/mm^3
Hepatic
- Bilirubin ≤ 2.0 mg/dL* NOTE: *Unless due to lymphoma or Gilbert's syndrome
Renal
- Creatinine ≤ 2.0 mg/dL
Cardiovascular
- Ejection fraction ≥ 45% by echocardiogram or MUGA
Pulmonary
- DLCO ≥ 50% of predicted (corrected for alveolar volume)
Immunologic
- No known HIV positivity
- No active infection requiring oral or IV antibiotics
- No autoimmune or other disease requiring long-term systemic steroids or other long-term immunosuppressants
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Able to tolerate high-dose therapy
- No other malignancy within the past 3 years except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- No prior bone marrow transplantation
Endocrine therapy
- Not specified
Radiotherapy
- Concurrent radiotherapy for disease progression after high-dose cyclophosphamide allowed at the discretion of the principal investigator
Surgery
- Not specified
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Immunotherapy
All participants received two days of rituximab, then four days of high-dose cyclophosphamide followed by filgrastim.
Participants then received six doses of KGEL vaccine over 24 weeks interspersed with four additional doses of rituximab.
|
Vaccine was administered at weeks 0, 4, 8, 12, 16, and 24 at a dose of 1 x 10^8 cells per dose.
The first dose was given on Day +1.
5 mcg/kg/day starting on Day +6 until ANC is >= 1000/mcL.
Otros nombres:
375 mg/m^2/day on Days -10, -7, and at weeks 4, 5, 6, and 7.
Otros nombres:
50 mg/kg/day on Day -3, -2, -1, and 0.
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Number of Participants With Grade 3-5 Adverse Events
Periodo de tiempo: Up to 36 months
|
Number of participants who experienced at least one grade 3-5 adverse event by CTCAE 3.0 that was attributed to protocol intervention.
|
Up to 36 months
|
Percentage of Participants With an Increase in Frequency of LMP2-specific CD8+ T Cells
Periodo de tiempo: Change from 3 months to 6 months
|
Percentage of participants with an increase in frequency of LMP2-specific CD8+ T cells.
Increase in frequency is defined as at least one order of magnitude higher than baseline measurement.
|
Change from 3 months to 6 months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Survival
Periodo de tiempo: Up to 6 years
|
Median number of months that participants were alive (overall survival) and alive without disease relapse or new diagnosis of myelodysplasia or acute leukemia (event-free survival).
|
Up to 6 years
|
Days to Neutrophil and Platelet Engraftment
Periodo de tiempo: Up to 46 days
|
Median number of days to absolute neutrophil count (ANC) >= 500/mcL and platelet count >=20000/mcL.
|
Up to 46 days
|
Colaboradores e Investigadores
Colaboradores
Investigadores
- Silla de estudio: Richard Ambinder, MD, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
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 (Actual)
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 del sistema inmunológico
- Neoplasias por tipo histológico
- Neoplasias
- Trastornos linfoproliferativos
- Enfermedades linfáticas
- Trastornos inmunoproliferativos
- Linfoma
- Enfermedad de Hodgkin
- Efectos fisiológicos de las drogas
- Mecanismos moleculares de acción farmacológica
- Agentes antirreumáticos
- Agentes antineoplásicos
- Agentes inmunosupresores
- Factores inmunológicos
- Agentes antineoplásicos, alquilantes
- Agentes alquilantes
- Agonistas mieloablativos
- Agentes antineoplásicos inmunológicos
- Ciclofosfamida
- Rituximab
Otros números de identificación del estudio
- J0528
- P30CA006973 (Subvención/contrato del NIH de EE. UU.)
- P50CA096888 (Subvención/contrato del NIH de EE. UU.)
- NA_00035358 (Otro identificador: JHMIRB)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre KGEL vaccine
-
TASK Applied ScienceTerminadoCOVID-19 | SARS-CoV-2Sudáfrica