Completado

Phase II Study of Glivec (Imatinib) in Locally Advanced and/or Metastatic Soft Tissue Sarcomas Expressing the t(17;22)(q22;q13) Translocation Resulting in a COL1A1/PDGF-beta Fusion Protein i.e. DermatoFibroSarcoma Protuberans (DFSP) and Giant Cell Fibroblastoma (GCF)

0 criterios cumplidosConsulta de un vistazo cómo tu perfil cumple con cada criterio de elegibilidad.
Qué se está evaluando

Colección de datos

Quiénes están siendo reclutados

Fibrosarcoma+2

+ Neoplasias

+ Neoplasias por tipo histológico

A partir de 18 años
Ver todos los criterios de elegibilidad
Cómo está diseñado el estudio

Estudio de Tratamiento

Fase 2
Intervencional
Inicio del estudio: abril de 2004
Ver detalles del protocolo

Resumen

Patrocinador PrincipalEuropean Organisation for Research and Treatment of Cancer - EORTC
Última actualización: 14 de enero de 2026
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Fecha de inicio: 1 de abril de 2004

Fecha en la que se inscribió al primer participante.

OBJECTIVES: Primary * Determine the therapeutic activity of imatinib mesylate in patients with locally advanced or metastatic dermatofibrosarcoma protuberans or giant cell fibroblastoma. * Determine the progression-free rate at 14 weeks in patients treated with this drug. Secondary * Determine objective response rate, progression-free survival, and overall survival in patients treated with this drug. * Determine the duration of response in patients treated with this drug. OUTLINE: This is an open-label, non-randomized, multicenter study. Patients receive oral imatinib mesylate twice daily for at least 14 weeks in the absence of disease progression or unacceptable toxicity. Patients with stable disease after 14 weeks receive imatinib mesylate for 12 additional weeks. Patients with a partial or complete response at 14 weeks undergo surgical resection if possible. If surgical resection of all remaining tumor is not possible OR if complete resection is not achieved (section margins positive), patients continue to receive imatinib mesylate in the absence of disease progression Patients are followed monthly for 6 months, every 3 months for 6 months, every 6 months for 2 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 44 patients will be accrued for this study within 2 years.

Título OficialPhase II Study of Glivec (Imatinib) in Locally Advanced and/or Metastatic Soft Tissue Sarcomas Expressing the t(17;22)(q22;q13) Translocation Resulting in a COL1A1/PDGF-beta Fusion Protein i.e. DermatoFibroSarcoma Protuberans (DFSP) and Giant Cell Fibroblastoma (GCF) 
NCT00085475
Patrocinador PrincipalEuropean Organisation for Research and Treatment of Cancer - EORTC
Última actualización: 14 de enero de 2026
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Protocolo

Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.
Detalles del Diseño

Se reclutarán 17 pacientes

Número total de participantes que el ensayo clínico espera reclutar.

Estudio de Tratamiento

Estos estudios prueban nuevas formas de tratar una enfermedad, condición o problema de salud. El objetivo es determinar si un nuevo medicamento, terapia o enfoque funciona mejor o tiene menos efectos secundarios que las opciones existentes.

Elegibilidad

Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.
Condiciones
Criterios

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

FibrosarcomaNeoplasiasNeoplasias por tipo histológicoNeoplasias del tejido conjuntivoSarcoma

Criterios

DISEASE CHARACTERISTICS: * Histologically confirmed dermatofibrosarcoma protuberans or giant cell fibroblastoma * Locally advanced or metastatic disease * Measurable disease * Not amenable to surgery, radiotherapy, or combined modality therapy with curative intent * Documented progressive disease within the past 3 months * Previously irradiated lesions must show disease progression * Tumor expressing COL1A1/PDGF-beta by fluorescence in situ hybridization * Translocation t(17;22)(q22;q13) * No prior chemotherapy OR previously treated with 1, and only 1, line of combination chemotherapy with ifosfamide and doxorubicin OR 2 lines of single-agent therapy OR relapsed within 6 months after adjuvant chemotherapy PATIENT CHARACTERISTICS: Age * 18 and over Performance status * WHO 0-2 Life expectancy * Not specified Hematopoietic * Absolute neutrophil count ≥ 2,000/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Hemoglobin ≥ 9 mg/dL\* NOTE: \*Transfusion allowed Hepatic * SGOT or SGPT ≤ 2.5 times upper limit of normal (ULN) (5 times ULN if hepatic metastases are present) * Bilirubin ≤ 1.5 times ULN * No uncontrolled hepatic disease Renal * Creatinine ≤ 1.5 times ULN * No uncontrolled renal disease Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 3 months after study participation * HIV negative * No uncontrolled diabetes * No active or uncontrolled infection * No concurrent severe or uncontrolled medical disease * No medical, psychological, familial, sociological, or geographical condition that would preclude study participation, compliance, or giving informed consent * No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer currently in complete remission PRIOR CONCURRENT THERAPY: Biologic therapy * More than 28 days since prior biologic therapy * No concurrent filgrastim (G-CSF) or sargramostim (GM-CSF) * No concurrent anticancer biologic agents Chemotherapy * See Disease Characteristics * More than 28 days since prior chemotherapy * No concurrent chemotherapy Endocrine therapy * Not specified Radiotherapy * See Disease Characteristics * At least 6 months since prior radiotherapy * No concurrent radiotherapy * Concurrent palliative radiotherapy allowed provided radiotherapy will not be administered to a target lesion Surgery * Not specified Other * More than 28 days since prior investigational drugs * No concurrent therapeutic anticoagulation therapy with warfarin * Concurrent low-molecular weight heparin or mini-dose warfarin for prophylaxis of central venous catheter thrombosis allowed * No other concurrent anticancer agents * No other concurrent investigational drugs * No other concurrent cytostatic agents * No other concurrent tyrosine kinase inhibitors

Plan de Estudio

Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.
Objetivos del Estudio

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 7 ubicaciones

Suspendido

Institut Jules Bordet

Brussels, BelgiumVer ubicación
Suspendido

U.Z. Gasthuisberg

Leuven, Belgium
Suspendido

Institut Bergonie

Bordeaux, France
Suspendido

CHU de la Timone

Marseille, France
Completado7 Centros de Estudio