- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00003067
Biological Therapy in Treating Patients With Primary or Advanced Glioma
Intracavitary Interleukin-2 (IL-2) and Lymphokine-Activated Killer (LAK) Cell Therapy for Malignant Gliomas
RATIONALE: Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing. Interleukin-2 may stimulate a person's white blood cells to kill cancer cells in patients with primary or advanced glioma.
PURPOSE: Clinical trial to study the effectiveness of biological therapy with interleukin-2 and lymphokine-activated killer cells in treating patients who have primary, recurrent, or refractory malignant glioma.
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
OBJECTIVES:
- Confirm the antitumor efficacy of intracavitary interleukin-2 plus autologous lymphokine-activated killer cells in patients with primary, recurrent or refractory malignant gliomas.
- Determine whether the induction of a regional, intracavitary, eosinophilia is a prognosticator of response to immunotherapy and long term survival in these patients.
OUTLINE: Patients receive cytoreductive tumor surgery and/or biopsy and implantation of intracavitary Ommaya reservoir prior to therapy induction.
Patients undergo outpatient leukapheresis on day -4 or -5, and cells are incubated ex vivo with interleukin-2 (IL-2). Lymphokine-activated killer (LAK) cells and IL-2 are infused on day 1. Bolus infusions of low-dose IL-2 are administered on days 3, 5, 8, 10, and 12, followed by a rest period on days 13-24. The course is repeated on day 25 starting with leukapheresis. Therapy courses are repeated for up to 1 year for stable disease or response to therapy. Maintenance doses repeat every 4-6 months thereafter.
Disease restaging is done every 8-12 weeks.
PROJECTED ACCRUAL: A total of 30 patients per year will be enrolled.
Tipo de estudio
Fase
- Fase 2
Contactos y Ubicaciones
Ubicaciones de estudio
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New York
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Staten Island, New York, Estados Unidos, 10305
- Staten Island University Hospital
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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 or radiographically proven primary, recurrent, or refractory malignant gliomas (glioblastoma, anaplastic astrocytoma, and mixed anaplastic glioma)
- Must be a candidate for neurosurgical biopsy or tumor debulking
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance Status:
- Karnofsky 60-100%
Life Expectancy:
- Greater than 4 months
Hematopoietic:
- Granulocytes greater than 1,500/mm^3
- Platelet count greater than 50,000/mm^3
- PT and PTT within normal limits
Hepatic:
- Bilirubin no greater than 1.5 times upper limit of normal
Renal:
- Creatinine less than 1.5 mg/dL
- Creatinine clearance greater than 60 mL/min
Cardiovascular:
- No congestive heart failure
- No coronary artery disease
- No serious cardiac arrhythmias
- No prior myocardial infarction
Pulmonary:
- No major pulmonary problems
Other:
- No history of neurologic disease (except related to brain tumor)
- No psychosis
- No impaired cognitive function
- No significant concurrent medical illness
- No active infection requiring antibiotic therapy
- Not pregnant
- Negative pregnancy test
- Fertile patients must use effective contraception
- Adequate peripheral veins to permit leukapheresis, or placement of indwelling central vascular access device
- No hepatitis B or C
- HIV negative
- No prior autoimmune disease
- Allergy to gentamicin is allowed
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- At least 6 weeks since prior immunotherapy and recovered
- No concurrent immunotherapy
Chemotherapy:
- At least 4 weeks since prior chemotherapy (6 weeks for carmustine) and recovered
- No concurrent chemotherapy
Endocrine therapy:
- Reduction or elimination of corticosteroids
- Not greater than 0.15 mg/kg/day dexamethasone equivalent
Radiotherapy:
- At least 6 weeks since prior radiotherapy and recovered
- No concurrent radiotherapy
Surgery:
- Prior surgery is allowed
Other:
- Concurrent therapy with acetaminophen, anticonvulsant agents, and headache pain medications is allowed
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
Colaboradores e Investigadores
Patrocinador
Investigadores
- Silla de estudio: Roberta L. Hayes, PhD, Immune Therapy, LLC
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
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 del Sistema Nervioso
- Neoplasias por tipo histológico
- Neoplasias
- Neoplasias por sitio
- Neoplasias Glandulares y Epiteliales
- Neoplasias Neuroepiteliales
- Tumores neuroectodérmicos
- Neoplasias De Células Germinales Y Embrionarias
- Neoplasias De Tejido Nervioso
- Glioma
- Neoplasias del Sistema Nervioso
- Neoplasias del Sistema Nervioso Central
- Agentes antiinfecciosos
- Agentes Antivirales
- Agentes Anti-VIH
- Agentes antirretrovirales
- Agentes antineoplásicos
- Aldesleukin
Otros números de identificación del estudio
- CDR0000065739
- NYWCCC-0902499
- NYWCCC-IMMUNE-0902499
- SIUH-RP-96-004
- NCI-V97-1326
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