EUCTR2004-002538-20-GB进行中（未招募）1 期
Phase 2 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 rearrangement i.e. DermatoFibroSarcoma Protuberans (DFSP) and Giant Cell Fibroblastoma (GCF)
European Organisation for Research and Treatment of Cancer0 个研究点目标入组 44 人开始时间: 2005年3月31日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 44
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •? Patients must have histologically proven locally advanced or metastatic DFSP or GCF. In case of metastatic disease, tissue can be taken either from the primary tumor or from the metastasis provided the biopsy can be taken without mutilating surgery.
- •? Patients must have been evaluated by a multidisciplinary team (medical oncologist, surgical oncologist) before entering in the trial.
- •? Patients must have DFSP or GCS not amenable to surgery, radiation or combined modality treatment with curative intent. Palliative radiation therapy is permitted provided it will not be given to a target lesion.
- •? Patients must have measurable disease, as defined in the RECIST criteria (see chapter on Response evaluation).
- •? Patient’s tumor surroundings must be marked on the skin after the surroundings have been optionally identified by ultrasound. This marking should be done using tatouage technique.
- •? Patient must have progressive disease documented in the last 3 months.
- •? Patients must have frozen tumor or paraffin embedded tissue available for
- •immunohistochemical and molecular analysis and for central review of eligibility.
- •? Patients must have WHO performance status <=2.
- •? Patients must be >=18 years.
- •? Patients have been either not pretreated with chemotherapy or with no more than one line of combination chemotherapy with ifosfamide and doxorubicin or 2 lines of single agent therapy or be relapsing within 6 months after the end of adjuvant chemotherapy.
- •? The patient must not have received chemotherapy, biologic therapy or any other investigational drug for any reason within 28 days prior to treatment start.
- •? Patients previously irradiated on the lesion must have progressive disease and irradiation should have been stopped for at least six months.
- •? No concomitant treatment with other cytostatic agents or tyrosine kinase inhibitors.
- •? Patient must have adequate liver function as defined by a serum bilirubin = 1.5 x the institutional upper limit of normal (IULN), SGOT or SGPT = 2.5 x the institutional upper limit of normal (or = 5 x the institutional upper limit of normal if hepatic metastases is present) obtained within 14 days prior to first registration.
- •? Patient must have an adequate renal function as defined by a serum creatinine = 1.5 x the institutional upper limit of normal obtained within 14 days prior to first registration.
- •? Patient must have absolute neutrophil count (ANC) = 2.0x109/l and a platelet count = 100x109/l obtained within 14 days prior to first registration. Baseline hemoglobin must be = 9 g/dl (this may be achieved by transfusion if needed).
- •? Patient may not have a severe and/or uncontrolled concurrent medical disease (e.g., uncontrolled diabetes, uncontrolled chronic renal or liver disease, or active uncontrolled infection, e.g., HIV).
- •? Patient must not be pregnant or nursing. Women/men of reproductive potential must agree to use an effective contraceptive method throughout the study and for up to 3 months following discontinuation of study drug. Women of reproductive potential must have a negative serum
- •pregnancy test within 7 days prior to treatment start. Post-menopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential.
- •? No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or an
排除标准
- 未提供
研究者
相似试验
已完成
2 期
Phase2 Study of Glivec (imatinib mesylate, formerly known as STI571) in Patients with Relapsed or Refractory Sarcomas with c-kit or PDGFR ExpressioJPRN-jRCT1091220003Office of Imatinib phase 2 study40
已完成
2 期
Phase2 Study of Glivec (imatinib mesylate, formerly known as STI571) in Patients with Relapsed or Refractory Sarcomas with c-kit or PDGFR ExpressioSarcoma with c-kit or PDGFR expression by immunohistochemistryJPRN-C000000073Office of Imatinib phase2 study40
进行中（未招募）
不适用
Phase II study of Glivec (imatinib mesylate) in patients with advanced neuroblastoma - NDHigh risk NeuroblastomaMedDRA version: 6.1Level: PTClassification code 10029260EUCTR2005-005778-63-ITISTITUTO GIANNINA GASLINI
已完成
2 期
Glivec plus chemotherapy in blast-phase CML and Ph+ ABlast-Phase Chronic Myeloid LeukemiaPhiladelphia Chromosome-Positive Acute Lymphoblastic LeukemiaCancer - Leukaemia - Acute leukaemiaCancer - Leukaemia - Chronic leukaemiaACTRN12605000072617Australasian Leukaemia and Lymphoma Group41
已完成
2 期
Imatinib Mesylate in Treating Patients With Locally Advanced or Metastatic Dermatofibrosarcoma Protuberans or Giant Cell FibroblastomaSarcomaNCT00085475European Organisation for Research and Treatment of Cancer - EORTC17