- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00088101
STA-5312 Administered on Alternate Weekdays Every Two Weeks to Patients With Hematologic Malignancies and Patients With Solid Tumors
3 de diciembre de 2008 actualizado por: Synta Pharmaceuticals Corp.
Phase I Trial of STA-5312 Administered on Alternate Weekdays Every Two Weeks to Patients With Hematological Malignancies and Patients With Solid Tumors
The purpose of this study is to determine the safety, toxicity and patient tolerance of STA-5312 administered intravenously to patients with relapsed or refractory hematological malignancies and patients with solid tumors.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción
42
Fase
- Fase 1
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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California
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Pamona, California, Estados Unidos, 91767
- Wilshire Oncology Medical Group
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Florida
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Jacksonville, Florida, Estados Unidos, 32207
- Baptist Cancer Institute
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Illinois
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Chicago, Illinois, Estados Unidos, 60637
- University of Chicago
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02111
- Tufts New England Medical Center
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New Jersey
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Newark, New Jersey, Estados Unidos
- Newark Beth Israel Medical Center
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North Carolina
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Charlotte, North Carolina, Estados Unidos, 28203
- Carolinas Healthcare System
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Tennessee
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Memphis, Tennessee, Estados Unidos, 38120
- The West Clinic
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Nashville, Tennessee, Estados Unidos, 37203
- The Sarah Cannon Cancer Center
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Male and female patients 18 years or older with one of the following malignancies:
- Histologically or cytologically confirmed hematological malignancy (other than Acute Myeloid Leukemia and Myelodysplastic Syndrome) and if treatment is medically indicated, or,
- Histologically-confirmed non-hematological malignancy that is metastatic or unresectable and for which no standard therapy is available.
- Patients with CLL, PLL, CML, CTCL, ATL, and Non-Hodgkin's Lymphoma may be entered if they are refractory to or have relapsed following conventional chemotherapy regimens such as alkylating agents (e.g. chlorambucil and cyclophosphamide), anthracycline combinations [e.g. CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone)], and/or purine analogues (e.g. fludarabine monophosphate and 2-CDA) and are not currently being considered for re-treatment with conventional regimens
- Patients with CLL and other leukemic malignancies will be staged according to the modified Rai staging criteria [low-risk, intermediate-risk and high risk]. All patients in the high-risk group (Stage III and IV) are eligible. Intermediate risk patients (Stage I and II) with one or more criteria of active disease (such as progressive lymphocytosis, lymphadenopathy, and splenomegaly, weight loss > 10% within 6 months, extreme fatigue, fever and/or night sweats without evidence of infection, etc.) are also eligible
- ECOG Performance Status of 0-2
- Life expectancy of greater than 12 weeks.
- Patients must have acceptable organ and marrow function at screening and pre-dose visits as defined below unless approved medically by the clinical investigator.
- Absolute neutrophils count greater than 1,000 cells/ul for patients with hematologic malignancies and ≥1,500 cells/ul for patients with solid tumors
- Platelets greater than 100,000/ul
- Hgb greater than 8.5 g/dL
- Total bilirubin must be <1.5 mg/dL or < 2X upper limit of normal
- AST (SGOT) < 2.5 times the upper limit of normal
- ALT (SGPT) < 2.5 times the upper limit of normal
- Adequate renal function (serum creatinine < 2.0 mg/dL or a calculated creatinine clearance greater than 50 mL/min)
- Electrocardiogram without evidence of clinically significant conduction abnormalities or active ischemia as determined by the investigator.
- NCI grade 0-1 left ventricular ejection fraction within 30 days of dosing.
- The effects of STA-5312 on the developing human fetus are unknown. Therefore, women of childbearing potential (defined as women under 50 years of age or history of amenorrhea for < 12 months prior to study entry) must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a female patient become pregnant or suspect she is pregnant while participating in this study, she should inform the treating physician immediately.
- Ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria:
- Women who are pregnant or lactating.
- Patients who have had chemotherapy, radiotherapy (except palliative radiation delivered to < 20% of bone marrow), immunotherapy, or corticosteroids ( > 10 mg/day of prednisone or equivalent) within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
- The use of nitrosoureas or mitomycin C within 6 weeks prior to study entry.
- Patients with prior peripheral blood stem cell rescue or bone marrow transplantation.
- History of primary brain tumors or active brain metastases. (Patients with previously treated brain metastases who are not receiving corticosteroids or anticonvulsants may be considered for enrollment)
- History of stroke or other significant neurologic limitations within 6 months prior to study enrollment
- Use of any investigational agents within 4 weeks of study enrollment.
- History of severe allergic reactions to excipients (e.g. Tween 80) or had hypersensitivity reactions to other chemotherapeutic agents similar in structure to STA-5312.
- Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements, as determined by the investigator.
- History of active CNS-lymphoma, AIDS-related lymphoma, or any uncontrolled severe medical illness or infection.
- Grade 2 or higher sensory or motor neuropathy at screening.
- Major surgery (excluding that for diagnosis) within 4 weeks of enrollment.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de febrero de 2004
Finalización del estudio
1 de diciembre de 2004
Fechas de registro del estudio
Enviado por primera vez
20 de julio de 2004
Primero enviado que cumplió con los criterios de control de calidad
20 de julio de 2004
Publicado por primera vez (Estimar)
21 de julio de 2004
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
4 de diciembre de 2008
Última actualización enviada que cumplió con los criterios de control de calidad
3 de diciembre de 2008
Última verificación
1 de diciembre de 2008
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 5312-01
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 STA-5312
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Synta Pharmaceuticals Corp.TerminadoTumores sólidos avanzados o metastásicosEstados Unidos
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Emory UniversitySynta Pharmaceuticals Corp.TerminadoCarcinoma de células escamosas de la cavidad oral en estadio IVA | Carcinoma de células escamosas de laringe en estadio IVA | Carcinoma de células escamosas orofaríngeas en estadio IVA | Carcinoma de células escamosas de hipofaringe en estadio I | Carcinoma de células escamosas de laringe... y otras condicionesEstados Unidos
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David M. Jackman, MDMassachusetts General Hospital; Beth Israel Deaconess Medical Center; Synta Pharmaceuticals...TerminadoCáncer de pulmón de células pequeñasEstados Unidos
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International Bio serviceAún no reclutando
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Memorial Sloan Kettering Cancer CenterSynta Pharmaceuticals Corp.TerminadoCáncer de mamaEstados Unidos
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Synta Pharmaceuticals Corp.Terminado
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Massachusetts General HospitalDana-Farber Cancer Institute; Beth Israel Deaconess Medical Center; Synta Pharmaceuticals...TerminadoCáncer esofagogástricoEstados Unidos
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National Institute of Allergy and Infectious Diseases...TerminadoEnfermedad de CrohnEstados Unidos
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Dana-Farber Cancer InstituteMassachusetts General Hospital; Beth Israel Deaconess Medical Center; Brigham and... y otros colaboradoresTerminado
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Massachusetts General HospitalDana-Farber Cancer Institute; Beth Israel Deaconess Medical Center; Synta Pharmaceuticals...Terminado