NL-OMON49405
Completed
Phase 2
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
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Brain cancer
- Sponsor
- TELIX International Pty Ltd
- Enrollment
- 2
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
Trial is onging in other countries
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- 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.
Exclusion Criteria
- •\- 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
Outcomes
Primary Outcomes
Not specified
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