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-0910

Centre Oscar Lambret0 个研究点目标入组 12 人开始时间: 待定最近更新: 2024年4月29日

适应症

试验速览

暂无简介。

•Histologically or cytologically confirmed diagnosis of rhabdomyosarcoma
•Relapsed / progressive disease (previously shown respons to chemo-therapy)
•Measurable disease (defined as lesions that can be measured in 3 dimensions by medical imaging techniques such as CT or MRI).
•Age > 6 months and <=50 years
•Karnofsky performance status (PS) 70-100% (for patients > 12 years of age)
•OR Lansky Play Score 70-100 % (for patients <= 12 years of age)
•Life expectancy >= 12 weeks
•Adequate bone marrow-, renal- and hepatic function (as defined in protocol)
•Fertile patients must use effective contraception
•Written informed consent of patient and/or parents/ guardians

•Other malignancy, including secondary malignancy
•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)
•Concurrent enzyme-inducing anticonvulsants (EIAC), including phenytoin, phenobarbital, or carbamazepine
•Concurrent administration of any of the following: rifampicin, voriconazole, itraco-nazole, ketoconazole, aprepitant
•Prior irinotecan or temozolomide administration
•Less then 3 weeks since prior myelosuppressive therapy (6 weeks for nitrosourea, 2 weeks for vincristine, vinorelbine, vinblastine and low-dose cyclophosphamide)
•Less 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

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