EUCTR2012-004508-36-IT进行中（未招募）1 期
Brentuximab vedotin (SGN-35) as salvage therapy for males with advanced and platinum-resistant germ-cell tumors. An open label, single group, Phase 2 trial
Fondazione Michelangelo - Avanzamento dello studio e cura dei tumori0 个研究点目标入组 24 人开始时间: 2013年3月7日最近更新:
适应症
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
- 24
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
- Male
入选标准
- •1.Age = 18 years
- •2.Male patients, even if surgically sterilized, (i.e., status post vasectomy) agree to practice effective barrier contraception during the entire study period and through 6 months after the last dose of study drug, or agrees to completely abstain from heterosexual intercourse.
- •3.Confirmation of GCT histology based on pathologic review at Fondazione INT Milan.
- •4.Presence of a CD30-positive embryonal carcinoma component. It should be assessed on either research biopsy immediately prior to start of brentuximab (preferably) or on archival tissue of the most recent post-chemotherapy viable residual (in the absence of easily accessible disease or in presence of clinical contraindications to biopsy).
- •5.Unequivocal progression of measurable disease (measurable disease will consist of abnormalities on 2-dimensional imaging or raised tumor markers) as documented by either:
- •a.Tumor biopsy of new, growing or unresectable lesions demonstrating viable non-teratomatous GCT (enrollment on this study for consolidation treatment after resection of viable GCT is not allowed).
- •b.Increasing or abnormally elevated serum tumor markers (HCG or AFP). Increasing LDH alone does not constitute progressive disease.
- •6.A minimum of 2 and a maximum of 3 platinum-based chemotherapy lines for metastatic disease (enrollment will take place either as 3rd or 4th line of treatment). EXCEPT for primary mediastinal GCTs where failure of first-line chemotherapy ( 2nd line setting) is accepted.
- •7.First-line therapy should consist of at least 3 cycles of cisplatin-based chemotherapy.
- •8.Prior single, tandem or triple high-dose chemotherapy course given as front-line or salvage therapy is allowed.
- •9.Recovery from prior surgery.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 12
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 12
排除标准
- •1.Failure to meet any of the above inclusion criteria.
- •2.Less than 2 prior lines of cisplatin-based chemotherapy (including one cisplatin-based chemotherapy line followed by high-dose therapy). Except for primary mediastinal GCTs where less than 2 prior lines of cisplatin-based chemotherapy (2nd line setting) is accepted.
- •3.Prior Treatment with any of the following anti-cancer therapies:
- •4.radiation therapy, surgery or tumor embolization are allowed with a washout period of 14 days prior to enrolment OR
- •5.chemotherapy, immunotherapy, biologic therapy, investigational therapy or hormonal therapy are allowed with a washout period of 14 days or five half-lives of a drug (whichever is longer) prior to enrolment.
- •6.Patients with late-relapse (defined as relapse occurring after at least 2 years from the date of completion of the last chemotherapy regimen) whose disease is completely surgically resectable (and for whom initial surgical extirpation is recommended) are ineligible. Patients with unresectable late disease relapse are eligible.
研究者
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