EUCTR2010-023135-42-NL进行中（未招募）1 期
INTERNATIONAL RANDOMIZED PHASE II TRIAL OF THE COMBINATION OF VINCRISTINE AND IRINOTECAN WITH OR WITHOUT TEMOZOLOMIDE (VI OR VIT) IN CHILDREN AND ADULTS WITH REFRACTORY OR RELAPSED RHABDOMYOSARCOMA - VIT
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 120
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
- •TUMOR CHARACTERISTICS :
- •Histologically or cytologically confirmed diagnosis of rhabdomyosarcoma (RMS) (new biopsy recommended)
- •Any Relapsed / progressive disease (in patients who have already presented a response to chemotherapy)
- •Refractory disease (defined as progression after receiving chemotherapy without prior response)
- •Patients must have measurable disease defined as lesions that can be measured in 3 dimensions by medical imaging techniques such as CT or MRI. Ascites, pleural fluid, bone marrow disease alone, and lesions seen on Tc scintigraphy or PET scan only are not considered measurable for these patients
- •PATIENT CHARACTERISTICS :
- •Age > 6 months and < or = 50 years
- •Karnofsky performance status (PS) (for patients > 12 years of age) OR Lansky Play Score for patients = 12 years of age) 0-100%
- •Life expectancy = 12 weeks
- •Adequate bone marrow function : Absolute neutrophil count = 1000/mm3, Platelet count = 100,000/mm3 (transfusion independent), Hemoglobin = 8.5 g/dl (transfusion allowed)
- •In case of bone marrow disease: Absolute neutrophil count = 500/mm3, Platelet count = 75,000/mm3
- •Adequate renal function : Serum creatinine < 1.5 X ULN for age. If serum creatinine > 1.5 ULN, creatinine clearance (or radioisotope GFR) must be >70 ml/min/1.73 m²
- •Adequate hepatic function : Total bilirubin = 1.5 times upper limit of normal (ULN) for age, except if the patient is known to have Gilbert’s syndrome. ALT and AST < 2.5 times ULN for age
- •Negative pregnancy test in females with childbearing potential
- •Fertile patients must use effective contraception
- •No active > grade 2 diarrhea or uncontrolled infection
- •No other malignancy, including secondary malignancy
- •Patient affiliated with a health insurance system. Applicable for French patients only
- •Written informed consent of patient and/or parents/guardians
- •PRIOR or CONCURRENT THERAPY :
- •More than 3 weeks since prior radiation therapy to the site of any progressive lesion that will be identified as a target lesion to measure tumor response
- •At least 3 weeks since prior myelosuppressive therapy (6 weeks for nitrosourea. 2 weeks for vincristine, vinblastine, vinorelbine or low dose cyclophosphamide)
- •No concurrent enzyme-inducing anticonvulsants (EIAC), including phenytoin, phenobarbital or carbamazepine
- •No concurrent administration of any of the following: rifampicin, voriconazole, itraconazole, ketoconazole, aprepitant, St John’s Wort
- •No prior irinotecan or temozolomide administration
- •Prior vincristine administration allowed
- •Concurrent palliative radiation therapy to sites allowed other than the main measurable target
- •Prior allo- or autologous SCT allowed
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 110
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 10
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Concomitant anti-cancer treatment
- •Pregnancy or breast feeding
- •Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption
- •Neuromuscular disorders (e.g. Charcot-Marie Tooth disease)
- •Uncontrolled intercurrent illness or active infection
- •Unavailable for medical follow-up (geographic, social or psychological reasons)
研究者
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