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
- Conditions
- Brain cancerGMB10029211
- Registration Number
- NL-OMON49405
- Lead Sponsor
- TELIX International Pty Ltd
- Brief Summary
Trial is onging in other countries
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 2
- 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.
- 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>EOS will be 12 months after 1st 131I-IPA infusion, or earlier, if progression<br /><br>is diagnosed on imaging.</p><br>
- Secondary Outcome Measures
Name Time Method <p>- To assess the maximum tolerated dose (MTD) of 131I-IPA administered<br /><br>concomitantly to 2nd line XRT in recurrent GBM<br /><br>- To evaluate the feasibility of a fractionated administration of 131IIPA<br /><br>- To evaluate the radiation absorbed dose to tumour from 131I-IPA<br /><br>- To explore the antineoplastic effect of 131I-IPA + XRT combination therapy<br /><br>- To explore a possible influence of MGMT promoter methylation status on the<br /><br>biological response to 131I-IPA + XRT combination therapy<br /><br>- To explore the occurrence and frequency of pseudo-progression (PsPD) in<br /><br>response to 131I-IPA + XRT combination therapy<br /><br>- To explore the cognitive function before, during and after therapy</p><br>