- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00668382
Evaluate The Toxicity And Feasibility Of Intra-Tumoral Injection
Phase I Study To Evaluate The Toxicity And Feasibility Of Intra-Tumoral Injection Of Alpha-Gal Glycosphingolipids In Patients With Advanced Or Refractory Solid Tumors
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 1
Contactos y Ubicaciones
Ubicaciones de estudio
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Massachusetts
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Worcester, Massachusetts, Estados Unidos, 01655-0108
- University of Massachusetts Medical School
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Patients with solid tumors who have failed standard therapies, or are not candidates for standard therapies.
- Patients must have at least one measurable lesion that is accessible and suitable for injection of the GSL alpha-GAL.
- Patients should not be undergoing any active treatment with chemotherapy, radiotherapy, or steroids (either because the patient or the treating physician have decided not to employ these therapies at this time, or because they had already been tried and failed). If they have been treated with these modalities, the treatments should have been completed at least two weeks prior to date of injection of GSL alpha-GAL.
- Patients should be judged by the investigator to be able to undergo safely the procedure needed to inject the tumor with GSL alpha-GAL.
- Age equal or over 18 years old.
- ECOG (Eastern Cooperative Oncology Group ) performance of less than 2. (International Normalized Ratio) INR less than 1.5 and a (Partial Thromboplastin Time) PTT no greater than normal limits within 1 week prior to intra-tumoral injection (For patients who requires invasive procedure for intra-tumoral injection).
Laboratory Criteria (completed equal or less 2 weeks before enrollment) Hematologic: (White Blood Cell Count) WBC equal or above 3500/millimeter-cubed or (Absolute Neutrophil Count) ANC equal or above 1500/millimeter-cubed and platelet count equal or above 100,000/ millimeter-cubed.
Hepatic: Total bilirubin equal or less 4.0 milligrams/deciliter. Renal: Creatinine equal or less 2.2 milligrams/deciliter.
- Patients must be negative for HIV (circulating antibody), Hepatitis B (circulating antigen), and Hepatitis C (circulating antibody).
- Patients should have an expected survival of more than 6 weeks and should not have other systemic anti-tumor treatments planned during this time frame.
Exclusion Criteria:
- Patients who are pregnant (as determined by a positive serum HCG (Human Chorionic Gonadotropin) in patients of childbearing potential) or nursing.
- Patients under the age of 18.
- Patients with severe infections or septicemia.
- Patients with a history of autoimmune disease.
- Patients in, or about to be in, active treatment with chemotherapy or steroids.
- Patients who refuse HIV/hepatitis testing and patients who do not sign an approved consent form.
- Patient has received other investigational drugs within 14 days before enrollment or is expected to participate in an experimental drug study during this study treatment.
- Serious medical or psychiatric illness likely to interfere with participation in this clinical study.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Alpha-Gal Glycosphingolipid injection
Intervention: Intratumoral injection of a single dose of Alpha-Gal Glycosphingolipid (0.1 mg,1mg, 10mg)
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Intra-tumoral injection of Alpha-Gal Glycosphingolipid to evaluate toxicity
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Number of Subjects With Greater Than Grade 3 or 4 Toxicity
Periodo de tiempo: 1 month
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Grade 3/4 Toxicity occurring in a participant within a month of intratumoral injection
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1 month
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Giles Whalen, MD, University of Massachusetts, Worcester
Publicaciones y enlaces útiles
Publicaciones Generales
- Lugade AA, Moran JP, Gerber SA, Rose RC, Frelinger JG, Lord EM. Local radiation therapy of B16 melanoma tumors increases the generation of tumor antigen-specific effector cells that traffic to the tumor. J Immunol. 2005 Jun 15;174(12):7516-23. doi: 10.4049/jimmunol.174.12.7516.
- Malmberg KJ. Effective immunotherapy against cancer: a question of overcoming immune suppression and immune escape? Cancer Immunol Immunother. 2004 Oct;53(10):879-92. doi: 10.1007/s00262-004-0577-x. Epub 2004 Jul 28.
- DiGiacomo A, North RJ. T cell suppressors of antitumor immunity. The production of Ly-1-,2+ suppressors of delayed sensitivity precedes the production of suppressors of protective immunity. J Exp Med. 1986 Oct 1;164(4):1179-92. doi: 10.1084/jem.164.4.1179. Erratum In: J Exp Med 1986 Dec 1;164(6):2131.
- Shimizu J, Yamazaki S, Sakaguchi S. Induction of tumor immunity by removing CD25+CD4+ T cells: a common basis between tumor immunity and autoimmunity. J Immunol. 1999 Nov 15;163(10):5211-8.
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
Otros números de identificación del estudio
- UM200702
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 Alpha-Gal Glycosphingolipid
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University of Massachusetts, WorcesterTerminado
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University of North Carolina, Chapel HillRevivicor, IncReclutamientoVómitos | Síndrome del intestino irritable | Dolor abdominal | Diarrea | Síndrome de Alfa-GalEstados Unidos
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University Health Network, TorontoOzmosis Research Inc.Terminado
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Assistance Publique - Hôpitaux de ParisShire International GmbHTerminado
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Chang Gung Memorial HospitalReclutamientoEnfermedad de FabryTaiwán