NL-OMON49405已完成2 期
A multi-centre, open-label, single-arm, dose-finding phase I/II study to evaluate safety, tolerability, dosing schedule, and preliminary efficacy of carrier-added 4-L-[131I]iodo-phenylalanine (131I-IPA), administered as single or repetitive injections in patients with recurrent glioblastoma multiforme (GBM), concomitantly to 2nd line external radiation therapy (XRT) - IPAX-1Study - 131I-IPA-TLX-101-001
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 2
研究概览
简要总结
Trial is onging in other countries
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- Previously confirmed histological diagnosis of GBM, with current clinical or
- •imaging evidence for first recurrence according to modified RANO criteria
- •(2017). History of GBM standard therapy (debulking surgery, followed by
- •radio-chemotherapy (50-60 Gy in 2 Gy fractions, temozolomide).
- •- Interval since end of 1st line XRT >=6 months
- •- Amino acid-based molecular imaging (preferably 18F-FET-PETor 11Cmethionine,
- •as institutionally established) indicating pathologically increased amino acid
- •uptake inside or in the vicinity of the tumour clearly discernible from
- •background activity.
排除标准
- •- Primary XRT dose >60 Gy
- •- Doses to organs at risk defined by Yasar and .Tugrul (2005) exceeded or
- •reached by prior radiation therapy; e.g. cumulative total dose on the optical
- •chiasm >54 Gy for 2 Gy/fraction, alpha/beta=2
- •- Multifocal distant recurrence, defined as tumour lesion outside the primary
- •XRT field, as evidenced by amino acid-based PET imaging
- •- Prior treatment with brachytherapy
- •- Prior treatment with bevacizumab
研究者
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