Status:
COMPLETED
131I-IPA and Concurrent XRT in Recurrent GBM
Lead Sponsor:
Telix Pharmaceuticals (Innovations) Pty Limited
Conditions:
Glioblastoma Multiforme
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
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-...
Detailed Description
The IPAX-1 study is an open-label, single-arm, randomised, parallel-group, multi-centre dose-finding study to evaluate ascending radioactive dose levels of 131I-IPA, intravenously administered using d...
Eligibility Criteria
Inclusion
- 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 11C-methionine, as institutionally established) indicating pathologically increased amino acid uptake inside or in the vicinity of the tumour, clearly discernible from background activity.
- Current indication for repeat radiation therapy as discussed at the multidisciplinary neuro-oncological tumour board meeting, planned as standard fractionated dose schedule (18\*2 Gy)
- Male or female ≥18 years of age.
- Karnofsky performance status ≥70. Life expectancy of at least 16 weeks.
- Haematological, liver and renal function test results as follows:
- WBC: \>3\*109/L
- Haemoglobin \>80 g/L
- PLT \>100\*109/L
- ALT, ALP, AST: ≤5 times upper international limit of normal (UILN)
- Bilirubin ≤3 times UILN
- Serum creatinine: within normal limits or \<120 μmol/L for patients aged 60 years or older
- Urine protein dipstick: no protein
- Female patients surgically sterile or postmenopausal for at least 2 years. Participants of generative potential agreeing to use effective contraception during the period of therapy and 6 months after the end of study.
- Written informed consent
Exclusion
- 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, alphas/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
- Baseline steroid requirement , exceeding physiologic replacement doses ( \<1.5 mg dexamethasone or equivalent per day)
- History or evidence of delayed-type hypersensitivity (DTH)-dependent chronic infection (e.g. tuberculosis, systemic fungal or parasitic infection), potentially exacerbating under systemic corticoid therapy
- Localisation of tumour related to brain stem or axis, unless sufficient reserve capacity (e.g. remnant resection cavity, marked atrophy) to accommodate possible post-procedural tissue reactions, or pre-therapeutic consent for emergency trepanation
- Haemostaseologic conditions, precluding catheterisation or invasive procedures
- Clinically significant illness or clinically relevant trauma within 2 weeks before the administration of the investigational product
- Known impairment of liver or kidney function or known liver or kidney disease, such as hepatitis, cirrhosis, renal failure
- Known human immunodeficiency virus (HIV) positive serology or chronically active hepatitis B or C
- Ongoing toxicity \> grade 2 NCI-CTC (version 4.03) from previous standard or investigational therapies
- Administration of another investigational medicinal product within 90 days prior to screening
- Expected non-compliance with longer-term admission at isolated nuclear medicine ward
- In pre-menopausal women: Pregnant as evidenced by a positive pregnancy test, or breast-feeding
- Patients with known phenylketonuria
Key Trial Info
Start Date :
April 9 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 31 2022
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT03849105
Start Date
April 9 2019
End Date
October 31 2022
Last Update
April 14 2023
Active Locations (5)
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1
Lake Macquarie Private Hospital
Gateshead, New South Wales, Australia, 2290
2
Kepler University Clinic
Linz, Austria, 4020
3
Medical University of Vienna
Vienna, Austria, 1090
4
The Netherlands Cancer Institute
Amsterdam, Netherlands, 1066